2 Table of Contents EXECUTIVE SUMMARY ................................ ................................ ................................ ...................... 3 I. BACKGROUND ................................ ................................ ................................ ................................ .................. 8 II. INERT INGREDIENT PROFILE ................................ ................................ ................................ ........................ 8 III. HUMAN HEALTH ASSESSMENT ................................ ................................ ................................ ................ 9 A. Summary of Toxicity Data ................................ ................................ ................................ ................ 9 B. Toxicity Endpoint Selection ................................ ................................ ................................ ............ 16 C. Special Considerations for Infants and Children ................................ ................................ ............... 17 IV. EXPOSURE ASSESSMENT ................................ ................................ ................................ ......................... 18 A. Dietary Exposure: ................................ ................................ ................................ ........................... 18 i. Acute exposure ................................ ................................ ................................ ................................ 18 ii. Chronic exposure ................................ ................................ ................................ ............................ 18 iii. Cancer exposure ................................ ................................ ................................ ............................ 20 B. Residential Exposure ................................ ................................ ................................ ...................... 20 C. Residential Post - Application Exposure ................................ ................................ .......................... 23 V. AGGREGATE RISK AND DETERMINATION OF SAFETY ................................ ................................ .... 27 A. Acute Dietary Risk ................................ ................................ ................................ ............................. 27 B. Chron ic Dietary Risk. ................................ ................................ ................................ ......................... 27 C. Aggregate Cancer Risk for U.S. Population ................................ ................................ ....................... 27 D. Short - Term Aggregate Risk ................................ ................................ ................................ ............... 27 E. Intermediate - Term Aggregate Risk. ................................ ................................ ................................ ... 28 F. Determination of Safety ................................ ................................ ................................ ...................... 28 VI. OCCUPATIONAL EXPOS URE/RISK PATHWAY ................................ ................................ ..................... 28 A. Occupational Handler Risk ................................ ................................ ................................ ............. 29 B. Occupational Post - Application Risk ................................ ................................ ............................... 30 VII. CUMULATIVE EXPSOURE ................................ ................................ ................................ ........................ 31 VIII. ENVIRONMENTAL JUSTICE STATEMENT ................................ ................................ ........................ 31 IX. ENVIRONMENTAL FATE CONSID ERATIONS ................................ ................................ ....................... 32 X. ECOTOXICITY ................................ ................................ ................................ ................................ .................. 33 XI. RISK CHARACTERIZATION ................................ ................................ ................................ ...................... 34 REFER ENCES ................................ ................................ ................................ ................................ ............................ 403 EXECUTIVE SUMMARY Wagner Regulatory Associates (7217 Lancaster Pike, Suite A. Hockessin, DE 19707) on behalf of Nichino America, Inc . ( 4550 New Linden Hill Road, Suite 501, Wilmington, DE 19808) is requesting t hat EPA expand the current N - (n - octyl) - 2 - pyrrolidone (NOP) tolerance exemption. N - (n - octyl) - 2 - pyrrolidone (CAS Reg. No. 2687 - 94 - 7 ) is currently approved for an inert ingredient tolerance exemption listed in 40 CFR 180. 1130 when used as a solvent in cotton defoliant formulations containing thidiazuron and diuron as active ingredients . Wagner Regulatory Associates requested that EPA expand it to include use as an inert ingredient ( solvent ) in formulations of pyraflufen - ethyl herbicide at a maximum concentrati on of 20% weight/weight. N - (n - octyl) - 2 - pyrrolidone has low acute toxicity. T he acute oral LD 50 = 2,050 mg/kg for rats ( Toxicity Category III). The acute dermal LD 50 > 2,000 mg/kg in rabbits (Toxicity category III) . A p rimary skin irritation study on rabbi ts showed that N - (n - octyl) - 2 - pyrrolidone is extremely irritating. The dermal sensitization study on guinea pigs was considered positive. No acute inhalation study was available in the database. There were three subchronic oral toxicity studies available i n the database. A 28 - day oral toxicity study in rats showed changes in general health, reduction in body weight gain and changes in hematological and biochemical parameters following treatment with 320 mg/kg/day, the highest dose tested, of N - (n - octyl) - 2 - p yrrolidone. The NOAEL = 55 mg/kg/day. In a 90 - day oral toxicity study in rats signs of systemic toxicity , reduced body weight gain and/or food consumption, increase absolute and relative liver weights and minimal to mild hepatocyte hypertrophy were observe d at 6000 ppm, the highest dose tested. The NOAEL was 600 ppm (53 mg/kg/day) . In a 90 - day oral toxicity study in dogs, a dose - related increase in both absolute and relative liver weights, neurological signs and body weight loss were observed at 90 mg/kg/da y. The NOAEL was 30 mg/kg/day. There were three mutagenicity and genoto xic i ty studies available in the database for N - (n - octyl) - 2 - pyrrolidone. An Ames test, a mouse lymphoma mutagenesis assay and a mouse micronucleus test were negative for mutagenicity a nd genotoxicity. No carcinogenicity studies were available in the database for N - (n - octyl) - 2 - pyrrolidone . The Agency used a qualitative structure activity relationship (SAR) database, DEREK11, to determine if there were structural alerts for potential ca rcinogenicity of for N - (n - octyl) - 2 - pyrrolidone . No structural alerts for carcinogenicity were identified for N - (n - octyl) - 2 - pyrrolidone. In the absence of any structural alerts and lack of mutagenicity concerns, N - (n octyl) - 2 - pyrrolidone is not expected to be carcinogenic. There was one developmental toxicity study for N - (n - octyl) - 2 - pyrrolidone performed on rats, which were dosed at 0, 50, 200 and 800 mg/kg bw/day. The m aternal NOAEL was determined to be 200 mg/kg bw/day and the m aternal LOAEL was 800 mg/kg bw/day based on ruffled fur, ventral recumbency, somnolence, apathy, dyspnea and comatose state. Other adverse effects observed were a reduction in food consumption and slight body weight loss during the4 first days of dosing and reduced corrected body wei ght gain. The d evelopmental NOAEL was 200 mg/kg and the d evelopmental LOAEL was 800 mg/kg based on statistically significantly reduced body weight and delay in skeletal ossification correlated with the severe maternal toxicity observed at this dosage. Th ere were no reproductive toxicity studies for N - (n - octyl) - 2 - pyrrolidone. While there are no reproductive, neurotoxicity and chronic toxicity studies for N - (n - octyl) - 2 - pyrrolidone, there is no evidence of effects on reproductive parameters or of any effects suggestive of neurotoxicity from the available subchronic studies. No immunotoxicity or neurotoxicity studies were available in the database for N - (n octyl) - 2 - pyrrolidone . No metabolism or pharmacokinetic studies were available in the database for N - ( n - octyl) - 2 - pyrrolidone . Section 408 of the Federal Food, Drug and Cosmetic Act (FFDCA) provides that EPA shall apply an additional margin of safety for infants and children in the case of threshold effects to account for prenatal and post natal toxicity a nd the completeness of the database on toxicity and exposure unless EPA determines that a different margin of safety will be safe for infants and children. EPA concludes that the FQPA safety facto r could be reduced from 10X to 3 X for N - (n octyl) - 2 - pyrrolid one based on lack of increased susceptibility of infants and children from exposures to N - (n - octly) - 2 - pyrrolidone, lack of neurotoxicity and immunotoxicity concerns and completeness of the database for risk assessment purpose. An acute toxicity endpoin t was not established because no endpoint of concern following a single exposure was identified in the available studies. A toxicity endpoint for chronic dietary assessment and inhalation and dermal exposure assessment was selected at 30 mg/kg/day based on the 90 - day toxicity study in dogs. This was based on changes in clinical pathological parameters (decrease in A/G ratio and increase in alkaline phosphatase and globulin and decrease in RBC, Hgb, Hct, albumin, and GGT) and statistically significant dose - r elated increases in both absolute and relative liver weights at the LOAEL of 90 mg/kg/day. An uncertainty factor 3 00 was for inter - species extrapolation (10X) , intra - individual variability (10X) and FQPA safety factor (3X) . An acute dietary risk assessme nt was not conducted because no endpoint of concern following a single exposure was identified in the available studies. A chronic dietary risk assessment was conducted using the endpoint from the 90 - day dog study. Based on the analysis of estimated diet ary risks for the total U.S. population and various population subgroups, the chronic dietary exposure estimates for N - (n - octyl) - 2 - pyrrolidone are below the A gency’s level of concern for all supported commodities with active pyraflufen ethyl registrations. The chronic dietary exposure estimates for the total U.S. population is 14.3 % and the highest exposed population subgroup, children 1 - 2 years old , is 59.4 % of the chronic population adjusted dose (cPAD).5 A cancer dietary exposure assessment was not condu cted because the Agency has not identified a cancer risk for N - (n - octyl) - 2 - pyrrolidone. The term “residential exposure” is used in this document to refer to non - occupational, non - dietary exposure (e.g., for lawn and garden pest control, indoor pest con trol, termiticides, and flea and tick control on pets). N - (n - octyl) - 2 - pyrrolidone may be used in inert ingredients in pesticide products that are registered for specific uses that may result in outdoor residential exposures. Based on the use pattern of the active ingredient which includes but is not limited to gol f courses, ornamental turf lawns, roadside, parks and sports fields, the major route of exposure is expected to be inhalation and dermal exposure. A screening level residential exposure and risk as sessment was completed for a representative sample product containing pyraflufen ethyl. The 20% limit of formulation for N - (n - octyl) - 2 - pyrrolidone and total application rate of 0.0163 lbs of inert ingredient per half acre was used for risk assessment. F or residential applicator exposure, three use scenarios were used based on the sample label, manually pressurized hand - wand, backpack sprayer and hose - end sprayer. The Margins of Exposures (MOEs) were calculated to be 51000, 25000 and 11000 respectively. The acceptable MOE is for N - (n - octyl) - 2 - pyrrolidone is 3 00 or above; therefore these scenarios do not exceed the Agency’s level of concern. For residential post - application exposure, adults and toddlers were assessed separately as well as a golfer scena rio . The adult contact consist s of dermal post - application contact with turf while the toddler scenarios include oral hand to mouth, incidental oral ingestion, oral object to mouth and dermal turf contact. The resulting MOEs were 2420 for adults and 686 fo r a total toddler combined exposure for all the scenarios. The acceptable MOE for N - (n - octyl) - 2 - pyrrolidone is 3 00 or above; therefore residential post - application exposures do not exceed the Agency’s level of concern for N - (n - octyl) - 2 - pyrrolidone. Sho rt - term residential aggregate exposure takes into account short - term residential exposure plus chronic exposure to food and water (considered to be a background exposure level). N - (n - octyl) - 2 - pyrrolidone is used as an inert ingredient in some pesticide pro ducts that are currently registered for uses that could result in short - term residential exposure . The adult short term aggrega te MOE was calculated to be 1122 and the toddler aggregate MOE to be 291 . Registration Division’s levels of concern are for MOEs that are less than 3 00, therefore the aggregate exposure MOE are not of concern. Occupational exposure scenarios selected by the Agency for assessment are evaluated based on likely maximum application rates for products which m ay contain the inert ingr edient. T he example label and the same application rates were used for the intermediate - and long - term exposure durations . Active ingredient application rates are corrected for the maximum amount of inert ingredient (20% limit) present in the final formul ations to determine exposure and risk from exposure to the inert ingredient. The acceptable MOE for N - (n - octyl) - 2 - pyrrolidone is set at 3 00 or above for occupational exposure assessment. Based on the sample label , the occupational exposure scenarios for g round applicators and for mixer/loaders preparing and applying liquid formulations were used. These are the occupational activities believed to be associated with the highest exp osures relative to the proposed label use patterns. Due to the lack6 of data to the contrary, dermal absorption is assumed to be 100%. The inhalation toxicity and dermal toxicity was also assumed to be equivalent to oral toxicity. Risks were calculated using the MOE approach, which is a ratio of the exposure to the toxicological poin t of departure (PoD). Occupational handler risks consisted of MOEs ranging from 4,200 to 4,200,000 and are considered not of concern. The Agency’s level of concern for occupational inhalation and dermal exposure for N - (n - octyl) - 2 - pyrrolidone is for MOEs < 3 00. Occupational post - application exposure is used to describe exposures that occur when individuals are present in an environment that has been previously treated with a pesticide (also referred to as re - entry exposure). Such exposures may occur when workers enter previously treated areas to perform job functions, including activities related to crop production, such as scouting for pests or harvesting. This assessment is considered to be a screening level assessment , demonstrating that there are minim al potential risks to workers re - entering fields treated with pesticides containing N - (n - octyl) - 2 - pyrrolidone as inert ingredients. Therefore an occupational post - application risk assessment was not performed. EPA has not found N - (n - octyl) - 2 - pyrrolidon e to share a common mechanism of toxicity with any other substances, and that N - (n - octyl) - 2 - pyrrolidone does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that N - ( - n - octyl) - 2 - pyrrolidone do es not have a common mechanism of toxicity with other substances. Potential areas of environmental justice concerns, to the extent possible, were considered in this human health risk assessment, in accordance with U.S. Executiv e Order 12898, "Federal Actions to Address Environmental Justice in Minority Populations and Low - Income Populations," http://www.eh.doe.gov/oepa/guidance/justice/eo12898.pdf . Environm ental fate data for N - (n - octyl) - 2 - pyrrolidone could not be found in the publically available scientific literature. The EPI (Estimation Programs Interface) Suite TM was used to model possible environmental fate properties of the N - (n - octyl) - 2 - pyrrolidone. B ased on the estimated modeling programs, N - (n - octyl) - 2 - pyrrolidone is believed to be readily biodegradable. Also based on the modeling, N - (n - octyl) - 2 - pyrrolidone is estimated to have a Log Kow of 3.33 which can be assumed to be only slightly mobile in soil s when converted to Log Koc. With primary biodegradation estimated to be days and ultimate biodegradation to occur in weeks, N - (n - octyl) - 2 - pyrrolidone is not expected to be very persistent in the environment and is therefore considered not of concern. The estimated Bioconcentration factor (BCF) is 73.29 which is also not expected to be of a concern The Ecological Structure Activity Relationships (ECOSAR) Class Program was used to estimate the aquatic toxicity of indus trial chemicals. However study citatio ns were also provided from both BASF and ISP MSDS. The ECOSAR predictions were reasonably close when compared with the experimental test results from BASF MSDS and the ISP MSDS. Based on the studies mentioned in the BASF and ISP MSDS it can be assumed that N - (n - octyl) - 2 - pyrrolidone is slightly toxic to aquatic fish on an acute basis. Also it can be assumed that N - (n - octyl) - 2 - pyrrolidone is slightly toxic to aquatic invertebrates on an acute basis. N - (n - octyl) - 2 - pyrrolidone is also slightly toxic to bobwhite quail on an acute basis. It is practically non - toxic to bobwhite7 quail on a chronic basis based on the dietary LC50. Overall N - (n - octyl) - 2 - pyrrolidone is not expected to be of great concern with respect to ecotoxicity. Taking into consideration all ava ilable information on N - (n - octyl) - 2 - pyrrolidone, EPA concludes that there is a reasonable certainty that no harm to any population s ubgroup will result from aggregate exposure to N - (n - octyl) - 2 - pyrrolidone when considering occupation al , dietary exposure and all other nonoccupational sources of pesticide exposure for which there is reliable information. Therefore, the amendment of an exemption from tolerance under 40 CFR 180.1130 for N - (n - octyl) - 2 - pyrrolidone (CAS Reg. No. 2687 - 94 - 7) when used as a pesticide inert ingredient solvent in formulations of pyraflufen ethyl herbicide at a maximum concentration of 20% weight/weight can be considered safe under section 408(q) of the FFDCA.8 I. BACKGROUND Wagner Regulatory Associates (7217 Lancaster Pike, Suite A. Hockess in, DE 19707) on behalf of Nichino America, Inc. (4550 New Linden Hill Road, Suite 501, Wilmington, DE 19808) is requesting that EPA expand the current N - (n - octyl) - 2 - pyrrolidone (NOP) tolerance exemption. N - (n - octyl) - 2 - pyrrolidone (CAS Reg. No. 2687 - 94 - 7) is already approved for inert ingredient tolerance exemption listed in 40 CFR 180.1130 when used as a solvent in cotton defoliant formulations containing thidiazuron and diuron as active ingredients. Wagner Regulatory Associates requested that EPA expand i t to include use as an inert ingredient solvent in formulations of pyraflufen ethyl herbicide at a maximum concentration of 20% weight/weight. The information presented in this document is summarized primarily from the EPA Inert Reassessment : Two Exemptio ns from the Requirement of a Tolerance for N - (n - dodecyl) - 2 - pyrrolidone (CAS Reg. No. 2687 - 96 - 9) and N - (n - octyl) - 2 - pyrrolidone (CAS Reg. No. 2687 - 94 - 7) as well as the included MRIDs and subsequent Data Evaluation Records (DERs) . In the Federal Register of June 22, 1994 (59 FR 32083), EPA issued a final rule establishing two exemptions from the requirement of a tolerance for N - (n - dodecyl) - 2 - pyrrolidone and N - (n - octyl) - 2 - pyrrolidone for its use as an inert ingredient solvent in cotton defoliant formulations containing thidiazuron and diuron as active ingredients . However the final rule was published prior t o the enactment of FQPA, and in June 2006 an Inert Reassessment was performed and new data are available . II. INERT INGREDIENT PROFILE A. Summary of Uses N - (n - octyl) - 2 - pyrrolidone is used in electronics and agrochemicals. It is used as a solvent in industrial chemicals, or as a chemical intermediate. It is also used as an inert ingredient (solvent) in cotton defoliants containing thidiazuron and diuron as a ctive ingredients. B. Physical Chemical Properties Some of the physical and chemical characteristics of N - (n - octyl) - 2 - pyrrolidone , along with its structure and nomenclature, are found in Table 1.9 Table 1. Physical and Chemical Properties of N - (n - octyl) - 2 - pyrrolidone Parameter Value Source

Structure Sigma - Aldrich MSDS

CAS # 2687 - 94 - 7 Molecular Weight (g/mol) 197.3 Common Names NOP 1 - Octyl - 2 - pyrrolidone 1 - Octylpyrrolidon - 2 1 - Octyl - 2 - pyrrolidone N - Octylpyrrolidone

Octylpyrrolidone Physica l State liquid BASF MSDS Odor Amine - like BASF MSDS Color Colorless to yellow BASF MSDS Melting Point (°C) - 26 BASF MSDS Boiling Point (°C @ 19 hPa ) 306 - 307 BASF MSDS

Density (g/cm 3 @ 20°C) 0.92 BASF MSDS Flash point (°C) 142 BASF MSDS Ignition Temp erature (°C) 225 BASF MSDS

Vapor Pressure ( mbar) 0.0008 (@ 20°C) 0.02 (@ 55°C) BASF MSDS Partition Coefficient (Log P ow ) 4.15 BASF MSDS Viscosity Dynamic (@ 25°C) 8 mPa.s. BASF MSDS Water Solubility (g/L @ 20°C ) 1g/L BASF MSDS pH 9.1 BASF MSDS
III. HUMAN HEALTH ASSESSMENT A. Summary of Toxicity Data Acute Oral Toxicity The acute oral LD 50 for N - ( n - octyl) - 2 - pyrrolidone, was found to be 2,050 mg/kg bw. Graded dose levels (630 - 5,000 mg/kg) of N - (n - octyl) - 2 - py rrolidone were administered to f ive group s of fasted Wistar - strain albino rats (5 male, 5 female per group). The animals were observed for pharmacological effe cts, external signs of toxicity and mortality over a 14 - day period. At the 630 mg/kg dose level, no gross changes were observed . The gastr ic mucosa was moderately reddened and intestinal mucosa severely reddened in 1 female10 which died at 24 hrs. At the 1,000 mg/kg dose level, 5 rats showed no gross changes. The other five were determined to have irritation to the intestinal and gastrointesti nal mucosa, abscess on abdominal cavity and abscess/lesions on lungs. 3 female rats died at 24 hrs. At the 1,580 mg/kg dose level, 7 rats showed no gross changes. 1 rat died at 6 hrs with intestinal mucosa moderately reddened and two others at 24 hrs with gastrointestinal mucosa reddened and multiple lobes of liver blanched. At 2,520 mg/kg dose level, no gross changes were observed in any rats and one died at 2 days also with no gross changes observed. At the highest dose of 5,000 mg/kg, 1 rat survived wit h no gross changes observed. The other 9 died started at 3 hrs and ranging to 3 days and observations included test artic le in stomach and intestine, lob es of liver mottled /blanched and kidneys blanched , loose feces and forestomach reddened. The NOAEL was determined to be 2,050 mg/kg. ( MRID 45511801 ) Dermal Toxicity The acute dermal LD 50 for N - (n - octyl) - 2 - pyrrolidone when tested undiluted was determined to be greater than 2 ,000 m g/kg bw. Six New Zealand white rabbits each received a single dermal applicati on of undiluted N - (n - octyl) - 2 - pyrrolidone at a dose level of 2 ,000 m g/kg bw. The skins of 3 animals were abraded, while the remaining animals’ skin remained intact. Test sites were occluded for 24 hours after treatment and daily thereafter for a total of 1 4 days. A gross necropsy was performed on all animals. The skin at the test sites showed crust formation, scaling and scarring. No gross internal changes were observed in any of the animals. There was no mortality reported and the NOAEL was 2,000 mg/kg bw. ( MRID 45511802 ) Inhalation Toxicity No inhalation toxicity studies were available in the database. Primary Eye Irritation N - (n - octyl) - 2 - pyrrolidone was found to be extremely irritating when tested as sold, with wash procedures reducing the severity of t he irritation observed. The 2% aqueous s uspension was nonirritating with and without washout procedures. Nin e New Zealand white rabbits received a single intra - ocular application of 0.1 mL of N - (n - octyl) - 2 - pyrrolidone. In both assays the eyes of 6 animals remained unwashed for 24 hours while the eyes of the remaining 3 animals were washed 30 seconds after instillation of the test materials. Observations of ocular irritation were recorded 24, 48, and 72 hours following instillation of test materials. Additio nal readings were made at 4, 7, 14, and 21 days in the assay where N - (n - octyl) - 2 - pyrrolidone was tested as sold. The eyes were scored for corneal opacity, iritis, conjunctivitis and other effects. The unwashed eyes resulted in cornea opacity becoming opaqu e and iris invisible and covering greater than three quarters up to the whole area of eye. Most irises were many folds above normal, congested and swollen. However they were still reacting to light but sluggish reaction. The conjunctivae were mainly red wi th individual vessels not easily discernible. The conjunctivae were mainly swollen with lids about half - closed. There was slight discharge from the conjunctivae with some animals showing signs of moistening of the lids and hairs adjacent to lids. N - (n - octy l) - 2 - pyrrolidone is considered extremely irritating. (MRID 45511803)11 Primary Skin Irritation N - (n - octyl) - 2 - pyrrolidone was found to be irritating to rabbit skin when tested as sold, and minimally irritating as a 2% suspension. The backs of 6 New Zealand w hite rabbits were closely c lipped and the skin on the right side was abraded by making longitudinal epidermal incisions. The skin on the left side was left intact. A single application of 0.5 mL of N - (n - octyl) - 2 - pyrrolidone, tested as sold, was made to eac h test site. In a second assay, an additional 6 rabbits received single applications of a 2% aqueous suspension of n - (n - octyl) - 2 - pyrrolidone. In both assays, the wrapping and compound were removed at 24 hours and the sites scored at 24 and 72 hours for ery thema and edema using the Draize scale. The mean scores at 24 and 72 hours were averaged to yield a primary irritation index of 7.45 for N - (n - octyl) - 2 - pyrrolidone, when tested as sold, and 0.50 when tested as a 2% gravimetric aqueous suspension. (MRID 4551 1803) Dermal Sensitization Twenty female albino guinea pigs received intradermal injections of 0.05% v /v N - (n octyl) - 2 - pyrrolidone in water and in Freund’s complete adjuvant (FCA) as well as FCA in water alone. One week after the injections, the same inte rscapular area was covered for 48 hours with a patch saturated with N - (n - octyl) - 2 - pyrrolidone 30% v/v in distilled water. During this inductio n p hase, 10 control animals were treated similarly with the exception that the test material was omitted from the injections and topical applications. Two weeks after induction period, the test and control animals were challenged topically u sing a patch saturated in 0.2 m L N - (n - octyl) - 2 - pyrrolidone, 10% v/v in distilled water applied to an anterior site on the flank a nd N - (n - octyl) - 2 - pyrrolidone, 5% v/v in distilled water applied in a similar manner to a posterior site. The patches were sealed to the flank covered for 24 hours. The challenge sites were evaluated at 24, 48, and 72 hours after patch removal. N - (n - octyl) - 2 - pyrrolidone produced evidence of delayed contact hypersensitivity in 2 of the 20 test animals. (MRID 45511806) The results of the available acute toxicity s tudies are summarized in Table 2 . Acute Toxicity Table 2 . Acute Toxicity Profile of N - (n - o ctyl) - 2 - pyrrolidone Study Type Results Toxicity Category MRIDs # /Reference Acute Oral

– rat LD 50 = 2050 III Nitka & Palanker 1986 MRID 45511801 Acute Dermal - rabbit >2000 mg/kg III Nitka & Palanker 1986 MRID 45511802 Acute I nhalation - N/A N/A N/A N/A Primary Eye Irritation - rabbit Extremely irritating N/A Nitka & Palanker 1986 MRID 45511803 Primary Skin Irritation - rabbit Extremely irritating N/A Nitka & Palanker 1986 MRID 45511803 Dermal Sensitization Guinea pig maxi mization test Positive for dermal sensitization in 2 of 20 animals tested N/A Reagan & Laveglia 1988 MRID 4551180612 Subchronic Toxicity
– Rats In a 28 - day oral toxicity study in rats (MRID 45511805) , the no - effect level of N - (n octyl) - 2 - pyrrolidone was de termined to be 55 mg/kg/day. At 320 mg/kg/day specific changes in general health, body weight gain, hematological and biochemical parameters were recorded. N - (n - octyl) - 2 - pyrrolidone formulated as a solution in corn oil, was administered to rats (5 males, 5 females per dosage level) by intragastic intubation at dosage levels of 0, 5, 55, or 320 mg/kg/day. Treatment was carried out once daily for 28 consecutive days. Similarly, cont rol animals received corn oil ( 5mL/kg/day) included: Statistically significant observations noted at the high dose le vel of 320 mg/kg day included: l ower body weight gains in females (week 3); lower packed cell volume (PCV) and red blood cell counts in males, corpuscular hemoglobin concentration (MCHC) in males; and higher glutamic pyruvic transaminase levels in females. In all other respects including food consumption, organ weights, macroscopic and microscopic pathology, no changes were noted that were considered to be treatment - related. In a 90 - day dietary toxicity study in rats (MRID 4266831 6 ), N - (n - octyl) - 2 - pyrrolidone was administered orally via diet to rats at dosage levels of 0, 60, 600, and 6 ,000 ppm (equivalent to 0, 6, 60 and 600 mg/kg/day) . Due to the lack of toxicity at the high - dose level, the concentration of the test diet was increased from 6,000 to 8,000 ppm (~600 to 800 mg/kg/day) on study day 29 and from 8,000 to 10,000 ppm (~800 to 1,000 mg/kg/day) on study day 43. Control animals were fed basal diet. All animals were observed daily for clinical signs of toxicity. Body w eights and food consumption were measured and recorded weekly. Clinical pathology and ophthalmology examinations were performed at or near the end of the treatment period. Surviving animals were sacrificed at the end of the treatment period. All tis sues collected from control and high dose animals, all tissues from animals sacrificed during the study and the lungs, liver, kidneys and gross lesions from all low - and mid - dose animals were processed for histopathological examination. N - (n - octyl) - 2 - pyrro lidone produced signs of systemic toxicity in both males and females at the 10,000 ppm level. Reduced body weight gain and/or food consumption , increased absolute and relative liver weights and minimal to m ild hepatocyte hypertrophy were observed in the 10 ,000 ppm group. No treatment related mortalities or clinical signs of toxicity were observed during the study and no treatment - related differences were noted in the clinical pathology, ophthalmology or gross necropsy observations for males or females in an y of the study groups. No treatment related changes were observed in body weight gain, feed consumption, organ weights and histopathology for males or females in the 60 and 600 ppm groups. Based on the study, a dose level of 600 ppm (equivalent to 60 mg/kg /day) was considered the NOAEL following dietary administration of N - (n - octyl) - 2 - pyrrolidone for at least 90 days. In a 90 - day oral toxicity study in dogs (MRID 42668317 ) , a dose level of 30 mg/kg/day was determined to be the NOAEL. N - (n - octyl) - 2 - pyrroli done was administered orally via capsule at dosage levels of 0, 30, 90, and 240 mg/kg/day. All animals were observed daily for clinical signs of toxicity. After treatment, all surviving animals were subjected to complete necropsy with histological examinat ion. Dose related neurological signs and body weight loss were observed at 90 and 240 mg/kg/day levels. Also at 90 and 24013 mg/kg/day, changes in clinical pathological parameters were observed and were dose related. In addition, dose - related increases in bo th absolute and relative liver weights were observed in all groups but were significant in only the 90 and 240 mg/kg/day groups. One female death occurred on day 42 in the 240 mg/kg/day group. Chronic Oral Toxicity No chronic studies were available in t he database. Developmental and Reproductive Toxicity Developmental studies - Rats In th e developmental toxicity study (MRID 42668318), N - (n - octyl) - 2 - pyrrolidone was administered orally by gavage, once daily, to pregnant female Wistar rats from day 6 t hrough day 15 post coitum, at dosages of 0, 50, 200, or 800 mg/kg bw/day in order to assess the effects on embryonic and fetal development. At 800 mg/kg/day, 1 dam died after the 7 th and 1 after the 10 th test article administration. The females of this gro up had marked clinical signs of reaction to treatment, reduced food consumption, slight bodyweight loss during the first day of dosing and reduced corrected bodyweight gain. The mean fetal body weight was reduced at this dosage, combined with a delay of sk eletal ossification. At 50 or 200 mg/kg/day, no effects of treatment with the test article on maternal or fetal parameters were evident. Based on the results of this study, the no observed adverse effect level (NOAEL) for the maternal and fetal parameters was considered to be 200 mg/kg bw/day. N - (n - octyl) - 2 - pyrrolidone did not reveal any teratogenic potential up to and including the highest dose tested (HDT) level of 800 mg/kg bw/day when administered to pregnant Wistar rats under the conditions described f

or this study. Reproduction studies - Rats No reproductive toxicity studies are available for N - (n - octyl) - 2 - pyrrolidone . Immunotoxicity No immunotoxicity studies were available in the database for N - (n - octyl) - 2 - pyrrolidone, however, no triggers for imm unotoxicity were observed in the available database. Neurotoxicity No neurotoxicity studies were available in the database for N - (n - octyl) - 2 - pyrrolidone . Mutagenicity and Genotoxicity N - (n - octyl) - 2 - pyrrolidone was tested, as sold, in the Ames assay (MR ID 42668319) with Salmonella typhimurium strains TA 1535, TA 1537, TA 1538, TA 98, and TA 100. Tests were conducted in all 5 strains with and without metabolic activation (induced S - 9 rat liver preparations). The entire assay was performed twice. No mutage nic activity was demonstrated by N - (n - octyl) - 2 - pyrrolidone when tested as sold in the Ames assay.14 In a Mouse Lymphoma Assay (MRID 42668320) , N - (n - octyl) - 2 - pyrrolidone was tested for its potential to induce mutations at the thymidine Kinase locus of L5128 Y TK+/ - mouse lymphoma cells in the presence and absence of exogenous metabolic activation. Based on the results of a range finding test the test article was tested in the assay at doses ranging 0.005 to 100 μL/mL which produced varying degrees of reduction in cell growth. The results of this assay indicate that N - (n - octyl) - 2 - pyrrolidone produced a negative response in cultures treated in either the absence of exogenous activation or the presence of Aroclor - induced rat liver S - 9 mix. In a Mouse Micronucleu s Assay (MRID 42668321 ) , mice were administered N - (n - octyl) - 2 - pyrrolidone by intragastric gavage at a dose level of 1,720 mg/kg, based on results of a preliminary toxicity test. Bone marrow smears were obtained at 24, 48, and 72 hours post - dosing and exami ned for the presence of micronuclei in polychromatic and normochromatic erythrocytes. The ratio of polychromatic to normochr o matic erythrocytes (P/N ratio) was also assessed. At sampling times mice treated with N - (n octyl) - 2 - pyrrolidone showed no significa nt increase in frequency of micronucleated polychromatic erythrocytes, nor was there a significant decrease in P/N ratio at any of the sampling times. N - (n - octyl) - 2 - pyrrolidone was found to be non - mutagenic at dose level of 1,720 mg/kg in this in vivo cyto genetic test. Carcinogenicity No carcinogenicity studies were available in the database for N - (n - octyl) - 2 - pyrrolidone . The Agency used a qualitative structure activity relationship (SAR) database, DEREK11, to determine if there were structural alerts fo r potential carcinogenicity of for N - (n - octyl) - 2 - pyrrolidone . No structural alerts for carcinogenicity were identified for N - (n - octyl) - 2 - pyrrolidone. In the absence of any structural alerts and lack of mutagenicity concerns, N - (n - octyl) - 2 - pyrrolidone is no t expected to be carcinogenic. Metabolism and Pharmacokinetics No metabolism or pharmacokinetics studies were available in the database for N - (n octyl) - 2 - pyrrolidone .15 Table 3 . Toxicology Profile for N - (n - octyl) - 2 - pyrroli done

Guideline No./

Study Type Doses Levels MRID No. (year)/References Results 28 Day oral toxicity

– rat 5, 55 and 320 mg/kg/day Smith et al. 1989 MRID 45511805 NOAEL = 55 mg/kg/day LOAEL = 320 mg/kg/day based on general health, body weight gain, hemat ological and biochemical parameters. 90 Day oral toxicity

– rat (N - (n - octyl) - 2 - pyrrolidone) 60, 600 and 6,000 ppm in diet initially and increased to 8,000 and 10,000 near conclusion of study Liao 1991 MRID 42668316 NOAEL = 600 ppm (53 mg/kg) LOAEL = Si gns of systemic toxicity in both males and females were observed at 10000 ppm. Reduced body weight gain and/or food consumption, increased absolute and relative liver weights and minimal to mild hepatocyte hypertrophy were observed in the 10000 ppm group. 90 day oral toxicity

– dog (N - (n - octyl) - 2 - pyrrolidone) 30, 90 240 mg/kg/day Liao 1991 MRID 42668317 NOAEL = 30 mg/kg/day LOAEL = 90 mg/kg/ day based on changes to clinical pathological parameters (decrease in A/G ratio and increase in alkaline phosphata se and globulin and decrease in RBC, Hgb, Hct, albumin, and GGT) and statistically significant dose - related increases in both absolute and relative liver weights. Also a dose - related minimal or mild hepatocellular hypertrophy was observed. Developmental T oxicity - rats (N - (n - octyl) - 2 - pyrrolidone) 0, 50, 200 and 800 mg/kg bw/day Biedermann 1991 MRID 42668318 Maternal NOAEL = 200 mg/kg bw /day Maternal LOAEL = 800 mg/kg bw/day based on ruffled fur, ventral recumbency, somnolence, apathy, dyspnea and comatos e state. Also reduction in food consumption and slight body weight loss during the first days of dosing and reduced corrected body weight gain. D e velopmental NOAEL = 200 mg/kg D evelopmental LOAEL = 800 mg/kg based on statistically significantly reduced bo dy weight and delay in skeletal ossification correlated with the severe maternal toxicity observed at this dosage. AMES Test (N - (n - octyl) - 2 - pyrrolidone) Up to 1500 μg/plate Jones et al. 1989 MRID 42668319 No evidence of mutagenic potential as obtained i n t his bacterial test system Mouse Lymphoma Mutagenesis Assay (N - (n - octyl) - 2 - pyrrolidone) Kirby 1990 MRID 42668320 Test article produced a negative response in cultures treated in either the absence of exogenous activation or the presence of Aroclor - in duced rat liver S - 9.

Mouse Micronucleus Test (N - (n - octyl) - 2 - pyrrolidone) Up to 1720 mg/kg Proudlock et al. 1989 MRID 42668321 At all sampling times mice treated with test substance showed no significant increase in the frequency of micronucleated polych romatic erythrocytes. No significant decrease in the ratio of polychromatic to normochromatic erythrocytes. No evidence of mutagenic potential or bone marrow cell toxicity when administered orally in this in vivo test procedure.16 B. Toxicity Endpoint Select ion In the toxicity database, t he lowest NOAEL was 30 mg/kg/day based on the 90 - day toxicity study in dog s based on changes in clinical pathological p arameters (decrease in A/G ratio and increase in alkaline phosphatase and globulin and decrease in RBC, Hg b, Hct, albumin, and GGT) and statistically significant dose - related increases in both absolute and relative liver weigh ts. Also a dose - related minimal or mild hepatocellular hypertrophy was observed . Table 4 . Summary of Toxicological Doses and Endpoin ts for N - (n - octyl) - 2 - pyrrolidone for Use in Human Health Risk Assessment Exposure/Scenario Point of Departure and Uncertainty/Safety Factors RfD, PAD, LOC for Risk Assessment Study and Toxicological Effects Acute dietary (General population including in fants and children) An acute effect was not found in the database therefore an acute dietary assessment is not necessary. Chronic dietary (All populations) NOAEL= 30 mg/kg/day UF A = 10 x UF H = 10 x FQPA SF = 3 x Chronic RfD = 30 mg/kg/day cPAD = 0. 1 mg /kg/day [ Chronic Toxicity/ Carcinogenicity - dog ] LOAEL = 90 mg/kg/day based on based neurological signs, body weight and changes in clinical pathological parameters Incidental oral short term (1 to 30 days) NOAEL= 30 mg/kg/day UF A = 10 x UF H = 10 x FQPA SF = 3 x LOC for MOE = 3 00 [ Chronic Toxicity/ Carcinogenicity - dog ] LOAEL = 90 mg/kg/day based on based neurological signs, body weight and changes in clinical pathological parameters Incidental oral intermediate - term (1 to 6 months) NOAEL= 30 mg/kg/day UF A = 10 x UF H = 10 x FQPA SF = 3 x LOC for MOE = 3 00 [ Chronic Toxicity/ Carcinogenicity - dog ] LOAEL = 90 mg/kg/day based on based neurological signs, body weight and changes in clinical pathological parameters Dermal short - term (1 to 30 days) Dermal (or oral) study NOAEL = 3 0 mg/kg/day (dermal absorption rate = 100 % UF A = 10 x UF H = 10 x FQPA SF = 3 x LOC for MOE = 3 00 [ Chronic Toxicity/ Carcinogenicity - dog ] LOAEL = 90 mg/kg/day based on based neurological signs, body weight and changes in clinical path ological parameters Dermal intermediate term (1 to 6 months) Dermal (or oral) study NOAEL = 3 0 mg/kg/day (dermal absorption rate = 100 % UF A = 10 x UF H = 10 x FQPA SF = 3 x LOC for MOE = 3 00 [ Chronic Toxicity/ Carcinogenicity - dog ] LOAEL = 90 mg/kg/day ba sed on based neurological signs, body weight and changes in clinical pathological parameters Inhalation short - term (1 to 30 days) Inhalation (or oral) study NOAEL= 3 0 mg/kg/day (inhalation absorption rate = LOC f or MOE = 3 00 [ Chronic Toxicity/ Carcinogenicity - dog ] LOAEL = 90 mg/kg/day based on based17 100%) UF A = 10 x UF H = 10 x FQPA SF = 3 x neurological signs, body weight and changes in clinical pathological parameters Inhalation (1 to 6 months) Inhalation (or oral) study NOAEL = 3 0 mg/kg/day (inhalat ion absorption rate = 100%) UF A = 10 x UF H = 10 x FQPA SF = 3 x LOC for MOE = 3 00 [ Chronic Toxicity/ Carcinogenicity - dog ] LOAEL = 90 mg/kg/day based on based neurological signs, body weight and changes in clinical pathological parameters Cancer (Oral, dermal, inhalation) Based on the lack of mutagenicity in N - (n - octyl) - 2 - pyrrolidone and the absence of structural alerts in the DEREK analysis, N - (n - octyl) - 2 - pyrrolidone is unlikely to be carcinogenic. UF A = extrapolation from animal to human (interspeci es). UF H = potential variation in sensitivity among members of the human population (intraspecies). UF L = use of a LOAEL to extrapolate a NOAEL. UF S = use of a short - term study for long - term risk assessment. UF DB = to account for the absence of data or other data deficiency. FQPA SF = Food Quality Protection Act Safety Factor. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose. MOE = margin of exposure. LOC = level of concern. C . Special Considerations for Infants and Children Section 408 of the FFDCA provides that EPA shall apply an additional margin of safety for infants and children in the case of threshold effects to account for prenatal and post natal toxicity and the completeness of the database on toxicity and e xposure unless EPA determines that a different margin of safety will be safe for infants and children. EPA concludes that the FQPA safety factor could be reduced to 3 X for N - (n - octyl) - 2 - pyrrolidone for the following reasons: i. The toxicity database for N - (n - octyl) - 2 - pyrrolidone con sists of 90 - day oral toxicity s tudies in rats and dogs, several mutagenicity studies and a developmental toxicity study. While there are no reproductive, neurotoxicity and chronic toxicity studies for N - (n - octyl) - 2 - pyrrolidone, there is no evidence of effects on reproductive parameters or any effects suggestive of neurotoxicity from the available subchronic studies. Additionally, the most sensitive endpoint selected seen in the 90 - day dog oral toxicity study is based on hemtatol ogical and clinical chemistry parameters; increases in both absolute and relative liver weights; and reduction in body weight gain/food consumption - effects which are not expected to be progressive and for which the resultant ex posure assessment is likely t o b e protective of chronic effects and characterize toxicity potential of N - (n - octyl) - 2 - pyrrolidone. Although additional data are unlikely to indicate more sensitive effects, EPA has retained a FQPA factor of 3X as a database uncertainty factor. No inhalat ion toxicity studies were available in the database; however, the only potential inhalation exposure to N - (n - octyl) - 2 - pyrrolidone is to pesticide applicators, and, even assuming that such exposure has some relevance to decisions on the FQPA safety factor, the inhalation exposure to N - (n - octyl) - 2 - pyrrolidone is negligible in comparison to exposure under other pathways. In18 these circumstances, neither retention nor removal of the FQPA safety factor would have a meaningful impact on assessment of risk from in halation exposure. ii. No evidence of immunotoxicity was observed in the available database. Slight changes in the clinical pathological parameters (decreases in albumin/globulin ratio and globulin levels) were not considered as an indication of an immu notoxic response since no effects on blood lymphocytes and no adverse findings in the spleen and thymus. Therefore, an immunotoxicity study is not required. iii. There are no residual uncertainties identified in the exposure databases. As described ear lier, EPA used worst case assumptions for the dietary food exposure assessment. EPA made conservative (protective) assumptions in the ground and surface water modeling used to assess exposure to N - (n - octyl) - 2 - pyrrolidone in drinking water. EPA used simila rly conservative assumptions to assess residential post application exposure of children as well as incidental oral exposure of children 1 - 2. These assessments will not underestimate the exposure and risks posed by N - (n - octyl) - 2 - pyrrolidone . IV . EXPOS URE ASSESSMENT A. Dietary Exposure: In evaluating dietary exposure to the N - (n - octyl) - 2 - pyrrolidone , EPA considered exposure under the petitioned for exemptions from the requirement of a tolerance. EPA assessed dietary exposures from N - (n - octyl) - 2 - pyrrolidon e in food as follows: i. Acute exposure . No adverse effects attributable to a single exposure of N - (n - octyl) - 2 - pyrrolidone were seen in the toxicity databases. Therefore, acute dietary risk assessment for N - (n - octyl) - 2 - pyrrolidone is not required.

ii. Chronic exposure . In conducting the chronic dietary exposure assessment using the Dietary Exposure Evaluation Model DEEM - FCID TM , Version 3.16 , EPA used food consumption information from the U.S. Department of Agriculture’s National Health and Nutrition Examination Survey, What We Eat I n America, (NHANES/WWEIA). This dietary survey was conducted from 2003 to 2008 . As to residue levels in food, n o residue data were submitted for N - (n - octyl) - 2 - pyrrolidone. In the absence of specific residue data, EPA has developed an approach which uses surrogate information to derive upper bound exposure estimates for the subject inert ingredient. Upper bound exposure estimates are based on the highest tolerance for a given commodity from a list of high use insecticides, herbicides, and fungicides. A complete description of the general approach taken to assess inert ingredient risks in the absence of residue data is contained in the memorandum entitled “Alkyl Amines Polyalkoxylates (Cluster 4): Acute and19 Chronic Aggregat e (Food and Drinking Water) Dietary Exposure and Risk Assessments for the Inerts.” (D361707, S. Piper, 2/25/09) and can be found at http://www.regulations.gov in docket ID number EPA - HQ - OPP - 2008 - 0738. In the dietar y exposure assessment, the Agency assumed that the residue level of the inert ingredient would be no higher than the highest tolerance for a given commodity. Implicit in this assumption is that there would be similar rates of degradation (if any) between the active and inert ingredient and that the concentration of inert ingredient in the scenarios leading to these highest of tolerances would be no higher than the concentration of the active ingredient. The Agency believes the assumptions used to esti mate dietary exposures lead to an extremely conservative assessment of dietary risk due to a series of compounded conservatisms. First, assuming that the level of residue for an inert ingredient is equal to the level of residue for the active ingredient w ill overstate exposure. The concentration of active ingredients in agricultural products is generally at least 50 percent of the product and often can be much higher. Further, pesticide products rarely have a single inert ingredient; rather there is gene rally a combination of different inert ingredients used which additionally reduces the concentration of any single inert ingredient in the pesticide product in relation to that of the active ingredient . Second, the conservatism of this methodology is comp ounded by EPA’s decision to assume that, for each commodity, the active ingredient which will serve as a guide to the potential level of inert ingredient residues is the active ingredient with the highest tolerance level. This assumption overstates residu e values because it would be highly unlikely, given the high number of inert ingredients, that a single inert ingredient or class of ingredients would be present at the level of the active ingredient in the highest tolerance for every commodity. Finally, a third compounding conservatism is EPA’s assumption that all foods contain the inert ingredient at the highest tolerance level. In other words, EPA assumed 100 percent of all foods are treated with the inert ingredient at the rate and manner necessary to produce the highest residue legally possible for an active ingredient. In summary, EPA chose a very conservative method for estimating what level of inert residue could be on food, and then use this methodology to choose the highest possible residue that could be found on food and assumed that all food contained this residue. No consideration was given to potential degradation between harvest and consumption even though monitoring data shows that tolerance level residues are typically one to two orders o f magnitude higher than actual residues in food when distributed in commerce. Accordingly, although sufficient information to quantify actual residue levels in food is not available, the compounding of these conservative assumptions will lead to a signif icant exaggeration of actual exposures. EPA does not believe that this approach underestimates exposure in the absence of residue data. In the case of N - (n - octyl) - 2 - pyrrolidone , EPA made specific adjustment s to the dietary exposure assessment to account for the use limitations of N - (n - octyl) - 2 - pyrrolidone. The20 refined herbicide residue profile created by Health Effects Division (HED) for the Inert Ingredient Assessment Branch (IIAB) for the dietary estimated exposure model (DEEM) was modified to include only commodity residues with active pyraflufen ethyl registrations. The residue levels established for the herbicide profile were retained for those specific commodities there would b e residues for the active ingredient to be used with N - (n - octyl) - 2 - pyrrol idone. In addition, t he amount of N - (n - octyl) - 2 - pyrrolidone that may be in formulations is no more than 20 % by weight in pesticide formulations. The residues and adjustment factor in the original herbicide residue profile were altered so that Adjustment Fa ctor 2 in the DEEM input file was set to 1 to reflect a 50% average content for inerts. For this analysis, Adjustment Factor 2 was changed to 0.4 t o reflect the 20% inert content, except for cotton commodities which are already exempted from a tolerance be cause of the current 40 CFR 180.1130 exemption for N - (n - octyl) - 2 - prryolidone and N - (n - dodecyl) - 2 - pyrrolidone when used as solvents in cotton defoliant formulations containing thidiazuron and diuron as active ingredients.. Table 5 . Summary of Chronic Diet ary Exposure and Risk for N - (n - octyl) - 2 - pyrrolidone

Population Subgroup cPAD (mg/kg/day) Chronic Exposure (mg/kg/day) %cPAD Total U.S. Population 0. 1 0.014 323 14.3 % All Infants (<1 year old) 0.033 758 33.8 % Children 1 - 2 years old 0.05 9367 59.4 % C hildren 3 - 5 years old 0.041 883 41.9 % Children 6 - 12 years old 0.023 487 23.5 % Youth 13 - 19 years old 0 .012 444 12.4 % Adults 20 - 49 years old 0.0 10126 10.1 % Adults 50+ years old 0.00 9008 9.0 % Females 13 - 49 years old 0.0 10055 10.1 % Based on the analy sis of estimated dietary risks for the total U.S. population and various population subgroups, the chronic dietary exposure estimates for N - (n - octyl) - 2 - pyrrolidone are below the agency’s level of concern for all supported commodities with active pyraflufen ethyl registrations. The chronic dietary exposure estimates for the total U.S. population is 14.3 % and the highest exposed population subgroup , children 1 - 2 years old is 59.4 % of the chronic population adjusted dose (cPAD). iii. Cancer exposure . It is co ncluded that N - (n - octyl) - 2 - pyrrolidone is unlikely to pose a cancer risk in human based on the lack of mutagenicity concerns and the lack of any structural alerts for carcinogenicity in Derek analysis. Therefore, a cancer dietary risk assessment for N - (n - o ctyl) - 2 - pyrrolidone was not conducted. B. Residential Exposure The term “residential exposure” is used in this document to refer to non - occupational, non - dietary exposure (e.g., for lawn and garden pest control, indoor pest control, termiticides, and flea and tick control on pets). N - (n - octyl) - 2 - pyrrolidone may be used in inert ingredients in pesticide products that are registered for specific uses that may result21 in outdoor residential exposures. Based on the use pattern of the active ingredient pyraflufen ethyl , which include s but is not limited to golf courses, ornamental turf lawns, roadsides, parks and sports fields , the major route s of exposure are expected to be inhalation and dermal exposure . A screening level residential exposure and risk assessmen t was completed for a sample product containing pyraflufen ethyl. The product label includes, among the registered sites of application, “established ornamental turf lawns (residential, industrial, and institutional) parks, cemeteries, athletic fields, gol f courses (fairways, aprons, tees and rou ghs), sod farms and similar turf areas.” The assessment is also based upon information taken from the sample product label and from “Standard Operating Procedures for Residential Pesticide Exposure Assessment” (Ja nuary 2013, Health Effects Division, Office of Pesticide Programs, Office of Chemical Safety and Pollution Prevention, U.S. Environmental Protection Agency, Washington, D.C.). The SOPs may be accessed at http://www.epa.gov/pesticides/science/residential - exposure sop.html . The product has a density of 7.66 lb/gallon. The inert comprises 20% of that or, 1.53 lb inert per gallon of product. 1.53 lb inert/gal ÷ 128 fl oz/g al = 0.012 lb inert/fl oz product. The label instructs lawn/turf spray mixtures be made at 8 fl oz product + 120 fl oz water. Thus for a gallon of spray mix ; 8 fl oz product * 0.012 lb inert/fl oz = 0.096 lb inert/gal of spray mix . The label further d irects a handler to apply 1.0 fl oz spray mix/1000 ft 2 . So, 0.096 lb inert/gal spray mix ÷ 128 fl oz/gal = 0.00075 lb inert/ fl oz spray mix. The Science Advisory Council for Exposure Policy Number 12 (Rev. 22 FEB 2001) indicates that for residential ha ndlers using a low - pressure hand - wand sprayer or a backpack sprayer the handler would apply 5 gallons of spray per day or would apply spray to an area of 1000 ft 2 /day ; further the policy indicates that for a residential handler using a hose - end sprayer, 10 0 gallons of spray would be applied per day or 0.5 A/day would be treated. Using area treated/day as the basis of comparison, a residential handler using either a low - pressure hand - wand or a backpack sprayer would be exposed to 0.00075 lb inert spray mi x/day. ( 1000 ft 2 /day treated at rate of 1.0 fl oz spray mix/1000 ft 2) A residential handler using a hose - end sprayer treating 0.5 A/day: 0.5 A = 21,780 ft 2 . At a rate of 1.0 fl oz inert spray mix/1000 ft 2 that equates to 21.78 fl oz inert spray mix/day . Since there is 0.00075 lb inert/fl oz spray mix:22 21.78 fl oz inert spray mix/day * 0.00075 lb inert/fl oz spray mix = 0.0163 lb inert/day (for one half an acre) . That further equates to 0.0326 lb inert/A application rate. The Agency notes with interes t that in the case of low - pressure hand - wand sprayer or backpack sprayer, that typically only a very small amount of a gallon of prepared spray mix would typically be used. The same is true for use of a hose - end sprayer but to a lesser extent. That leave s nearly a gallon of prepared spray mix that is evidently not typically needed for use. The Agency recommends that t he label be amended to avoid preparation of much more spray mix than might typically be needed. The product label appears to be intended p rimarily for commercial use. The application instructions don’t seem suited to typical homeowner use. As is described in the Standard Operating Procedures, the algorithm used to estimate exposure and dose is Unit Exposure * amount handled per day ÷ b ody weight. In this case there is no correction for dermal absorption. Lacking data to the contrary, the Agency assumes 100 % absorption via the dermal and inhalation routes of exposure. Body weight is assumed to be 80 kg. Table 6. Unit Exposures for L iquid Formulations (mg inert/pound handled) Route of Exposure Unit Exposure Mg/kg/day Total mg/kg/day Margins of Exposure Manually pressurized hand - wand Dermal 63 0.000591 0.000591 51000 Inhalation 0.018 0.000000169 Backpack sprayer Dermal 130 0.00 122 0.00122 25000 Inhalation 0.14 0.00000132 Hose - end sprayer Dermal 13.4 0.00273 0.00273 11000 Inhalation 0.022 0.00000448 Unit Exposure * Amount handled/day ÷ body weight = Average Daily Dose Manually pressurized hand - wand sprayer 63 mg inert/ lb handled * 0.0 0075 lb inert handled /day ÷ 80 kg bw = 0. 000591 mg/kg bw/day (dermal) 0.018 mg inert/lb handled * 0. 00075 lb inert handled/day ÷ 80 kg bw = 0.000 000169 mg/kg bw/day (inhal.) Total (dermal and inhalation) = 0. 000591 mg/kg/day. The Agency us es the Margin of Exposure (MOE) as an indication of levels of co ncern. Typically an MOE ≥ 3 00 does not exceed the Agency’s level of concern. Since the endpoint of concern for dermal and inhalation exposure assessment is based on same effects, the exposure estimates are also combined. Margins of Exposure are ratios o f the toxicological endpoint of concern (mg/kg bw/day)/average daily dose. In this case the endpoint of conce rn is 30 mg/kg bw/day. Thus 30 mg/kg bw/day/0. 000591 mg/kg bw/day = 51000 . Backpack sprayer 130 mg inert/lb handled * 0. 00075 lb h andled/day ÷ 80 kg bw = 0. 00122 mg/kg bw/day (dermal) 0.14 mg inert/lb handled * 0.0 0075 lb handled/day ÷ 80 kg bw = 0.000 00132 mg/kg bw/day (inhal.) Total (dermal and inhalation) = 0. 00122 mg/kg/day. Thus, 30 mg/kg bw/day/0. 00122 mg/kg bw/day = 25000 .23 Hose - end Spray er 13.4 mg inert/lb handled * 0.0 163 lb handled/day ÷ 80 kg bw = 0.0 0273 mg/kg bw/day (dermal) 0.022 mg inert/lb handled * 0.0 163 lb handled/day ÷ 80 kg bw = 0.0000 0448 mg/kg bw/day (inhal.) Total (dermal and inhalation) = 0.0 0273 mg/kg/day. Thus, 30 mg/ kg bw/day/0.0 0273 mg/kg bw/day = 1 1000 . Use of a manually pressurized hand - wand sprayer, a backpack sprayer or a hose - end sprayer under the conditions described in the product label results in Margins of Exposure which > 3 00 and therefore do not exceed th e Agency’s level of concern. C. Residential Post - Application Exposure Pesticide products applied to lawns and turf can result in post - application exposures to adults and children. Adults typically may experience dermal post - application exposure. Childre n may experience dermal post - application exposure as well as oral exposures that result from “hand - to - mouth” activities common to toddlers. In addition, since the product may be applied to golf courses, post - application exposure to golfers (adults and ado lescents) is also assessed. Following the guidance in the Residential SOPs and lacking Turf Transferrable Residue data, the Agency assumes 1 % (0.01) of the application rate is biologically available for dermal transfer. Earlier the rate of application p er acre was calculated to be 0.0326 lb inert/A. Therefore, 0.000326 lb inert/A is biologically available for dermal transfer. In calculations of post - application dermal exposure, the Agency uses Transfer Coefficients (cm 2 /hr) which are derived from numer ous studies of pesticide transfer from turfgrass. Lacking compound specific transfer data the default levels for liquid formulations are: 180,000 cm 2 /hr for adults and for children 1 - 2 years old 49,000 cm 2 /hr. Table 7 . Summary Residential Post - Applicat ion Exposures and Risks Activity Exposure (Dose) mg a.i./kg bw/day MOE Toddler short - term oral hand to mouth from contacting treated turf 0.00 0804 3 7,300 Toddler incidental oral ingestion of treated soil 0. 0193 1 554 Toddler oral object to mouth (turfgr ass) 0.00 000383 7.8M Adult dermal post applic turf contact 0. 0124 2420 Toddler dermal post applic turf contact 0. 0236 1270 Total Toddler Combined Exposure 1 0.0437 686 Adult golfer post app turf contact 0.00 00915 328,000 Child golfer post app turf cont act 0.00 0156 1 9 2,000 MOE = Margin of Exposure = No Observable Adverse Effect Level ÷ Average Daily Dose Dermal, Inhalation and Oral NOAEL = 30 mg a.i./kg bw/day 1 Combined exposure reflects the aggregation of dermal exposure to treated areas and HTM expos ure from treated areas (for children). * Total Combined Exposures = (NOAEL of 30 mg/kg/day)/ [Daily dose dermal + Daily dose HTM + Daily dose incidental oral + Daily dose OTM (mg/kg/day)] Post - application Dermal Exposure From Contacting Treated Lawn/Turf24 The algorithm is E = TTR 1 * CF1 * TC * ET where E = Exposure TTR 1 = Turf transferrable residue (μg/cm 2 ) CF1 = weight unit conversion factor (0.001 mg/μg) TC = Transfer coefficient ET = exposure time (hr/day) (1.5 hr). and where TTR 1 = AR * F * CF2 * CF3 TTR 1 = Turf Transferrable Residue on day t (μg/cm 2 ) AR = Application Rate F = Fraction of application rate as transferrable residue (unitless) (1.0%) CF2 = weight unit conversion factor 4.54 x 10 8 μg/lb) CF3 = area unit conversion factor (1.08 x 10 - 3 ft 2 /cm 2 or 2.47 x 10 - 8 acre/cm 2 ) 0. 0326 lb inert/A * 0.01 * 4.54 x 10 8 μg/lb * 2.47 x 10 - 8 acre/cm 2 = 0.0 0366 μg/cm 2 0.0 0366 μg/cm 2 * 0.001 mg/μg * 180,000 cm 2 /hr * 1.5 hr/day = 0.99 mg/day ÷ 80 kg bw = 0. 0124 mg/kg bw/day. 30 mg/kg bw/day/0. 0124 mg/kg bw/day = 2420 for an adult 0.0 0366 μg/cm 2 * 0.001 mg/μg * 49,000 cm 2 /hr * 1.5 hr/day = 0.269 mg/day ÷ 11.4 kg bw = 0. 0236 mg/kg bw/day. 30 mg/kg bw/day/0. 0236 mg/kg bw/day = 1270 for a toddler Post - Application Hand - to - Mouth Exposure E = [HR * (F M * SA H ) * ET * N

_ Replen) * (1 - (1 - SE) (Freq_HtM/N - Replen) )] where: E = exposure (mg/day) HR = hand residue loading (mg/cm 2 ) F M = fraction hand surface area mouthed/even (fraction/event) SA H = typical surface area of one hand (cm 2 ) ET = exposure time (hr/da y) N_Replen = number of replenishment intervals per hour (intervals/hr) SE = saliva extraction factor (i.e., mouthing removal efficiency Freq_HtM = number of hand - to - mouth contacts events per hour (events/hr) and HR = Fai hands * DE (calculated earlier u nder dermal post - application exposure) SA H * 2 where: HR = hand residue loading (mg/cm 2 ) Fai hands = fraction ai (material) on hands compared to total surface residue from dermal transfer coefficient (unitless) 0.06 for liquids DE = dermal exposure (mg) SA H = typical surface area of one hand (cm 2 ). HR = 0.06 * 0.269 mg = 0.000 54 mg/cm 2 150 cm 2 * 225 E = [0.000 054 mg/cm 2 * (0.127 * 150 cm 2 ) * 1.5 hr/day * 4 int/hr) * (1 - (1 - 0.48) 13.9/4 )] = 0.0 0917 mg/day Dose m g/kg bw/day = E mg /day = 0.0 0917 mg/day ÷ 11.4 kg = 0.00 0804 mg/kg bw/day BW kg MOE = NOAEL = 30 mg/kg bw/day = 3 7,300 Dose 0.00 0804 mg/kg bw/day Post - application Object - to - Mouth Exposure E = [O R*CF1*SAM O *(ET* N

_ Replen) * (1 - (1 - SE O ) (Freq_OtM/N - Replen) )] where: E = exposure (mg/day) OR = chemical residue loading on the object (turf) on day “t” CF1 = weight unit conversion factor (0.001 mg/μg) SAM O = area of the object surface that is mouthe d (cm 2 /event) ET = exposure time (hr/day) N

_ Replen = number of replenishment intervals per hour (intervals/hr) SE O = saliva extraction factor (i.e., mouthing removal efficiency) Freq

_ OtM = number of object - to - mouth contact events per hour (events/hr) an d where: OR = AR * F O * CF2 * CF3 OR = chemical residue loading on the object μg/cm 2 AR = application rate (lb ai/A) 0.52 lb/A in this case F O = fraction of residue available on the object (unitless) CF2 = weight unit conversion factor (4.54 x 10 8 μg /lb CF3 = area unit conversion factor (1.08 x 10 - 3 ft 2 /cm 2 or 2.47 x 10 - 8 acre/cm 2 ) Dose is normalized to body weight as Dose/11.4kg. OR = 0. 0326 lb/A * 0.01 * 4.54 x 10 8 μg/lb * 2.47 x 10 - 8 acre/cm 2 = 0.0 0366 μg/cm 2 E = 0. 00366 μg/cm 2 * 0.001 mg/μg * 10 cm 2 /event * (1.5hr/day*4interv/hr) * (1 - (1 - 0.48) (8.8/4) = 0.0 000437 mg/day 0.0 000437 mg/day ÷ 11.4 kg bw = 0.00 000383 mg/kg bw/day and 30 mg/kg bw/day ÷ 0.00 000383 mg/kg bw/day = 7.8M Post - application Incidental Soil Ingestion Exposure E xposure from incidental soil ingestion is calculated as follows: E = SR t * SI g R * CF1 where E = exposure/day (mg/day) SRt = soil residue on day “t” (μg/g) SI g R = ingestion rate of soil (mg/day) and CF1 = weight unit conversion factor (1 x 10 - 6 g/μg) and where SR t = AR * FS * (1 - F D ) t * CF2 * CF3 * CF4 where26 SR t = soil residue on day “t” (μg/g) AR = application rate FS = fraction of ai (or inert) available in uppermost cm of soil (fraction/cm) F D = fraction of residue that dissipates daily (unit less) t = post - application day on which exposure CF2 = weight unit conversion factor (4.54 x 10 8 μg/lb) CF3 = area unit conversion factor (1.08 x 10 - 3 ft 2 /cm 2 or 2.47 x 10 - 8 acre/cm 2 ) CF4 = soil volume to weight unit conversion factor (0.67 cm 3 /g soil) . Dose is normalized to body weight D = E BW D = dose (mg/kg bw/day) E = exposure (mg/day) SR t = 0. 0326 lb/A * 1 * (1 - 0.1) * 4.54 x 10 8 μg/lb * 2.47 x 10 - 8 acre/cm 2 * 0.67 cm 3 /g soil = 0.2 2 mg/day 0.22 mg/day ÷ 11.4 kg bw = 0. 019 3 mg/kg bw/day MOE = 30 mg/kg bw/day/0. 019 3 mg/kg bw/day = 1554 Adult and Adolescent Golfer Post - Application Dermal Exposure may be estimated using the convention stated in Science Advisory Council for Exposure draft Policy regarding “Golfer Exposure Assessment For Adults and Children” (24 August 2000). The draft policy states that adult and adolescent golfer dermal post - application exposure may be calculated as DE (t) (mg a.i./kg bw/day) = (TTR (t) (μg/cm2)) * TC (cm2/hr) * hr/day ÷ (CF (1000 μg/mg)) * BW (body weight (kg)) Where: DE (t) = dermal exposure at time (t) attributable to golfing on previously treated turf (mg /kg bw/day). TTR (t) = turf transferable residue at time t (μg/cm2) TC = Transfer Coefficient (500 cm2/hr) hr = exposure period (4 hours) CF = conversion factor to change μg to mg. BW = body weight (kg) (80 kg for adult; adjusted (multiplied) by a factor of 1.7 for child golfers)) Therefore, DE = 0.0 0366 μg/cm2 * 500 cm2/hr * 4 hr/day/1000μg/mg ÷ 80 kg bw = 0.00 00915 mg /kg bw/day. MOE for adult golfer is 30 mg a.i./kg bw/day ÷ 0.00 00915 mg/kg bw/day = 328,000 . The adult dose level is adjusted by a factor of 1.7 to estimate child golfer exposure therefore 0.00 0091 5 mg a.i./kg bw/day * 1.7 = 0.00 0156 mg a.i./kg bw/day. MOE for child golfer is 30 mg a.i./kg bw/day ÷ 0.00 0156 = 1 9 2,000. A MOE of 3 00 is adequate to protect golfers from dermal post application exposures to treated golf course turf. Inhalation ex posure is believed to be negligible. EPA has calculated the residential post - application exposures. All Margins of Exposure s (MOE s ) are > 3 00 and therefore the use patterns as described do not exceed the Agency’s level of concern.27 V. A GGREGATE RIS K AND DETERMINATION OF SAFETY EPA determines whether acute and chronic pesticide exposures are safe by comparing aggregate exposure estimates to the aPAD and cPAD. The aPAD and cPAD represent the highest safe exposures, taking into account all appropriat e safety factors (SFs). EPA calculates the aPAD and cPAD by dividing the Po D by all applicable UFs. For linear cancer risks, EPA calculates the probability of additional cancer cases given the estimated aggregate exposure. Short - , intermediate - , and chr onic - term risks are evaluated by comparing the estimated aggregate food, water, an d residential exposure to the Po D to ensure that the MOE called for by the product of all applicable UFs is not exceeded. A . Acute Dietary Risk . An acute aggregate risk assessment takes into account exposure estimates from acute dietary consumption of food and drinking water using the exposure assumptions discussed in section IV for acute exposure . However t here was no hazard attributable to a single exposure seen in the toxicity database for N - (n - octyl) - 2 - pyrrolidone ; therefore an acute aggreg ate risk assessment is not required. B. Chronic Dietary Risk. A chronic aggregate risk assessment takes into account exposure estimates from chronic dietary consumption of food and drinking water u sing the exposure assumptions discussed in section IV for chronic exposure . The chronic analysis was based on a 90 - day oral toxicity study in dogs with a NOAEL of 30 mg/kg/day and LOAEL of 90 mg/kg /day based on changes clinical pathol ogical parameters (decrease in A/G ratio and increase in alkaline phosphatase and globulin and decrease in RBC, Hgb, Hct, albumin, and GGT) and statistically significant dose - related increases in both absolute and relative liver weights . A 3 00 - fold uncerta inty factor (UF) (10x for interspecies extrapolation, 10x for intraspecies variation and 3 x for FQPA Safety Factor ) was incorporated . T he chronic dietary exposure from food and water to N - (n - octyl) - 2 - pyrrolidone is 14.3 % of the cPAD for the U.S. populatio n and 59.4 % of the cPAD for children 1 - 2 yrs old, the most highly exposed population subgroup. C . Aggregate Cancer Risk for U.S. Population . The Agency has not identified any concerns for carcinogenicity relating to N - (n - octyl) - 2 - pyrrolidone ; therefore, a cancer dietary exposure assessment was not performed and a ca n er aggregate risk assessment is not a concern. D. Short - Term Aggregate Risk . Short - term aggregate exposure takes into account short term residential exposure plus chronic exposure to food and water (considered to be a background exposure level). N - (n - octyl) - 2 - pyrrolidone is used as an inert ingredient in pesticide products that are currently registered for uses that could result in short - term residential exposure . T he Agency has determined tha t it is appropriate to aggregate chronic exposure through food and water with short - term residential exposures. Using the exp osure assumptions described in S ection IV, EPA has calculated the combined short - term aggregated food, water, and residential expo sures. The adult aggregate MOE was calculated to be 1 122 . Adult aggregate MOE combines average food and water exposure from the chronic dietary exposure with high end post application derm al exposure fro m contact with28 treated lawns. As the level of concern is for MOEs that are lower than 3 00, this MOE is not of concern. EPA has concluded the combined short - term aggregated food, water, and residential exposures result in an aggregate MOE of 291 for toddlers . Toddler ’s residential exposure includes total expo sures associated with contact with treated lawns (dermal , incidental oral ingestion of treated soil and hand - to - mouth exposures). As the level of concern i s for MOEs that are lower than 3 00, the estimated aggregate MOEs do not exceed the Agency’s level of concern . Table 8 . Short - Term Aggregate Risk Calculations for N - (n - octyl) - 2 - pyrrolidone Population PoD mg/kg/day LOC 1 Max Allowable Exposure 2 mg/kg/day Average Food & Water Exposure 3 mg/kg/day Residential Exposure 4 mg/kg/day Aggregate MOE (food and resi dential) 5 Adult 30 3 00 0. 1 0.014 323 0. 0124 11 22 Toddler 30 3 00 0. 1 0.05 9367 0. 0437 29 1 1 The LOC (Level of Concern) is based on the standard inter - , intra - species uncertainty factors and FQPA safety factor totaling 3 00. 2 Maximum Allowable Exposure (mg/ kg/day) = PoD (Point of Departure)/LOC. 3 Average Food & Water Exposure = Chronic Dietary Exposure Table 5 . 4 Residential Exposure = [Oral exposure + Dermal exposure + Inhalation Exposure]. 5 Aggregate MOE = [PoD/ (Avg Food & Water Exposure + Residential E xposure)]. E. Intermediate - Term Aggregate Risk. Intermediate - term aggregate residential exposure takes into account intermediate - term residential exposure plus chronic exposure to food and water (considered to be a background exposure level). Pyraflufen ethyl is not currently registered for uses that could result in intermediate - term residential exposure so an intermediate - term risk assessment for N - (n - octyl) - 2 - pyrrolidone was not performed. F . Determination of Safety . Based on these aggregate risk ass essments, EPA concludes that there is no concern to adults, infants or children from aggregate exposure to residues of N - (n octyl) - 2 - pyrrolidone . The short - term aggregate MOE for adults is 1122 and for toddlers are 291 . VI. O CCUPATIONAL EXPOSURE/RISK P ATHWAY The representative occupational scenarios selected by the Agency for assessment are evaluated based on likely maximum application rates for products which may contain the inert ingredient , for this assessment the example label previously used for the short - term exposure assessment will also be used , and similar application rates for products likely to contain the inert ingredient for the intermediate - and long - term exposure durations. Active ingredient application rates are corrected for the maxi mum amount of inert ingredient likely to be in the final29 formulations to determine exposure and risk from exposure to the inert ingredient by fungicide/insecticide or herbicide. RD traditionally considers a level of concern (LOC) for these risk assessm ents to be an MOE of 100 based on the standard 10X inter and 10X intra species extrapolation safety factors. However based on how the FQPA safety factor was derived, an additional 3X is included in the Occupational MOE bringing the total Occupational MOE t o 300. A. Occupational Handler Risk Exposure Scenarios Dermal and inhalation exposure are estimated using the Pesticide Handlers Exposure Database (PHED) and Outdoor Residential Exposure Task Force (ORETF) data. The analytical techniques are those developed by the Science Policy Council on Exposure (ExpoSAC), Hea l th Effects Division, Office of Pesticide Programs, U.S. Environmental Protection Agency. The quantitative exposure/risk assessment developed for occupational handlers to support the requested exempt ion for the inert ingredient is based on scenarios to represent the highest potential exposure. The algorithm used to estimate exposure is: U.E. * AR * Units Treated/day * absorption factor ÷ body weight. UE Unit Exposure in mg of material per lb of ma terial handled. Unit Exposures are derived in the Pesticide Handlers Exposure Database (PHED) and are recently summarized in the “Occupation Pesticide Handler Unit Exposure Surrogate Reference Table” US EPA Office of Pesticide Programs, March 2012 (unpubl ished) AR Application Rate in lbs of material per unit (acres) Units Treated/day - - In this case acres treated per day taken from the Health Effects Division Standard Operating Procedure 9.1 “Standard Values for Daily Acres Treated in Agriculture” Rev. 25 SEPT 2001 (unpublished) For groundboom sprays on sod farm, 80 A/day. AF Absorption factor - - in this case assumed to be 100 % by the dermal and inhalation routes of exposure BW Body Weight - - 80 kg for combined adults in the U.S. Taken from “Use o f New Human Body Weight Data as Presented in the EPA’s Exposure Factors Handbook: 2011 Edition” HED “HotSheet” No. 31. In this case occupational exposures are presented for ground applicators and for mixer/loaders preparing and applying liquid formulatio ns. These are the occupational activities believed to be associated with the highest exposures relative to the proposed label use pattern(s). Table 9 . Summary of Exposure & Risk to Occupatio nal Handlers From N - (n - octyl) - 2 - pyrrolidone Unit Exposure 1 ( m g inert /lb handled ) Applic ation Rate 2 ( lb inert /unit ) Units Treated 3 Avg. Daily Exposure 4 ( mg inert /kg bw/day ) MOE 5 Applicator, Open Cab Groundboom30 1. Unit Exposures are taken from “ Occupatio nal Pesticide handler Unit Exposure Surrogate Reference Table”, US EPA Office of Pesticide Programs, March 2012 . 2. Applic ation Rate = Calculated sample product label . 3. Units Treated are taken from the Health Effects Division Standard Operating Proce dure 9.1 “Standard Values for Daily Acres Treated in Agriculture: Rev. 25 SEPT 2001 (unpublished). 4. Average Daily Ex posure = Unit Exposure * Application Rate * Units Treated ÷ 8 0 kg Body Weight 5. MOE = Margin of Exposure = NOAEL ÷ ADE. Short term N OAEL = 30 mg/kg bw/day Dermal and inhalation absorption are assumed to be 100%. The inhalation toxicity and dermal toxicity is assumed to be equivalent to oral toxicity. Risks were calculated using the Margin of Exposure (MOE) approach, which is a ratio o f the exposure to the toxicological PoD. Occupational handler MOEs ranged from 4,200 to 4,200 ,000 . The Agency’s level of concern for occupational inhalation and dermal exposure is for MOEs < 3 00. In this case, the estimated MOEs are greater than 3 00 based on the assumption of 100 % dermal absorption. Therefore, the estimated MOEs are not of concern for occupational handler . B. Occup ational Post - A pplication Risk Exposure Scenarios The Agency uses the term post - application exposure to describe exposures that occur when individuals are present in an environment that has been previously treated with a pesticide (also referred to as re - entry exposure). Such exposures may occur when workers enter previously treated areas to perform job functions, including activ ities related to crop production, such as scouting for pests or harvesting. Post - application exposure levels vary over time and depend on such things as the type of activity, the nature of the crop or target that was treated, the type of pesticide applica tion, and the chemical’s degradation properties. In addition, the timing of pesticide applications, relative to harvest activities, can greatly reduce the potential for post - application exposure. Inhalation exposures are not typically calculated for occup ational post application scenarios because post - application inhalation exposures are generally believed to be negligible. This assessment is considered to be a screening level assessment , demonstrating that Dermal: S ingle layer, n o glove 0.0786 Inhalation: No respirator 0.00034 0. 0 326 lb inert /A 80 A/day Dermal: S ingle layer, n o glove 0.00256 Inhalation: No respirator 0.000 011 11,700 2,700,000 Mixing / Loading Liquid Dermal: Single layer, no gloves 0.22 Single layer, gloves 0.0376 Inhalation: No respirator 0.000219 0. 0 326 lb inert /A 80 A/day Dermal: Single layer, no gloves 0. 0072 Single layer, gloves 0.0012 Inhalation: No respirator 0.000 00714 4,200 25,0 00 4,200,00031 there are minimal potential risks to workers re - entering fields treated with pesticides containing N - (n - oc tyl) - 2 - pyrrolidone as inert ingredients. VI I . C UMULATIVE EXPSOURE Cumulative effects from substances with a common mechanism of toxicity . Section 408(b)(2)(D)(v) of FFDCA requires that, whe n considering whether to establish, modify, or revoke a tolerance, the Agency consider “available information” concerning the cumulative effects of a particular pesticide's residues and “other substances that have a common mechanism of toxicity.” EPA has not found N - (n - octyl) - 2 - pyrrolidone to share a common mechanism of toxicity wi th any other substances, and that N - (n - octyl) - 2 - pyrrolidone do es not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action , therefore, EPA has assumed that N - ( - n - octyl) - 2 - pyrrolidone do es not have a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cu mulative effects of such chemicals, see EPA's website at http://www.epa.gov/pesticides/cumulative . VIII . E NVIRONMENTAL JUSTICE STATEMENT Potential areas of environmental justice concerns, to the extent possible, were considered in this human health ris k assessment, in accordance with U.S. Executive Order 12898, "Federal Actions to Address Environmental Justice in Minority Populations and Low - Income Populations," http://www.eh.doe.gov/o epa/guidance/justice/eo12898.pdf . As a part of every pesticide risk assessment, OPP considers a large variety of consumer subgroups according to well - established procedures. In line with OPP policy, R D estimates risks to population subgroups from pestic ide exposures that are based on patterns of that subgroup’s food and water consumption, and activities in and around the home that involve pesticide use in a residential setting. Extensive data on food consumption patterns are compiled by the USDA under C SFII and are used in pesticide risk assessments for all registered food uses of a pesticide. These data are analyzed and categorized by subgroups based on age, season of the year, ethnic group, and region of the country. Additionally, OPP is able to asse ss dietary exposure to smaller, specialized subgroups and exposure assessments are performed when conditions or circumstances warrant. Whenever appropriate, non - dietary exposures based on home use of pesticide products and associated risks for adult appli cators and for toddlers, youths, and adults entering or playing on treated areas post - application are evaluated. Further considerations are currently in development as OPP has committed resources and expertise to the development of specialized software an d models that consider exposure to bystanders and farm workers as well as lifestyle and traditional dietary patterns among specific subgroups32 I X. E NVIRONMENTAL FATE CONSIDERATIONS Environmental fate data for N - (n - octyl) - 2 - pyrrolidone could not be found in the publically available scientific literature. The EPI ( Estimation Programs Interface) Suite TM was used to model possible environmental fate properties of the N - (n - octyl) - 2 - pyrrolidone. EPI Suite TM is a Windows ®

- based suite of physical/chemical pro perty and environmental fate estimation programs developed by the EPA’s Office of Pollution Prevention Toxics and Syracuse Research Corportion (SRC). EPI Suite TM uses a single input to run the following estimation programs: BIOWIN TM , WSKOWWIN TM , and BCFBAF TM . The results from these models are presented below. The BIOWIN TM model estimates aerobic and anaerobic biodegradability of organic chemicals using 7 different models. Two of these are the original Biodegradation Probability Program (BPPTM). The sevent h and newest model estimates anaerobic biodegradation potential. BIOWIN v4.10 Results for N - (n - octyl) - 2 - pyrrolidone Biowin1 (Linear Model Prediction): Biodegrades Fast Biowin2 (non - Linear Model Prediction): Biodegrades Fast Biowin3 (Ultimate Biodegradati on Timeframe): Weeks Biowin4 (Primary Biodegradtion Timeframe): Days Biowin5 (MITI Linear Model Prediction): Readily Degradable Biowin6 (MITI Non - Linear Model Prediction): Readily Degradable Biowin7 (Anaerobix Model Prediction): Does Not Biodegrade Fast Re ady Biodgradability Prediction: YES The WSKOWWIN TM model estimates an octanol - water partition coefficient using the KOWWINTM program, then estimates a chemical’s water solubility from this value and applicable correction factors if any. WSKOW v1.42 Resul ts for N - (n - octyl) - 2 - pyrrolidone Log Kow (estimated): 3.33 Log Kow (experimental): not available from database Log Kow used by Water solubility estimates: 3.33 Equation used to make Water Sol estimate: Log S (mol/L) = 0.796

– 0.854 log Kow

– 0.00728 MW + Correction (Used when Melting Point NOT available) Correction(s): Value No Applicable Correction Factors Log Water Solubility (in moles/L): - 3.486 Water Solubility at 25 deg C (mg/L): 64.5133 The BCFBAF TM program, formerly called BCFWINTM, this program es timates fish bioconcentration factor and its logarithm using two different methods. The first is the traditional regression b ased on log Kow plus any applicable correction factors, and is analogous to the WSKOWWIN TM method. The second is the Arnot - Gobas me thod, which calculates BCF from mechanistic first principles. BCFBAF also incorporates prediction of apparent metabolism half - life in fish, and estimates BCF and BAF for three trophic levels. BCFBAF v3.01 Results for N - (n - octyl) - 2 - pyrrolidone Summary Resu lts: Log BCF (regression - based estimate): 1.87 (BCF = 73.3 L/kg wet - wt) Biotransformation Half - Life (days): 0.133 (normalized to 10 g fish) Log BAF (Arnot - Gobas upper trophic): 1.65 (BAF = 44.7 L/kg wet - wt) BCF (Bioconcentration Factor): Log Kow (est imated): 3.33 Log KOW (Experimental): not avialble from database Log Kow used by BCF estimate: Log BCF = 0.6598 log Kow

– 0.333 + Correction Correction(s): Value No Applicable Correction Factors Estimated Log BCF = 1.865 (BCF = 73.29 L/kg wet - wt) Ba sed on the estimated modeling programs, N - (n - octyl) - 2 - pyrrolidone is believed to be readily biodegradable. Also based on the modeling, N - (n - octyl) - 2 - pyrrolidone is estimated to have a Log Kow of 3.33 which can be assumed to be only slightly mobile in soils when converted to Log Koc. With primary biodegradation estimated to be days and ultimate biodegradation to occur in weeks, N - (n - octyl) - 2 - pyrrolidone is not expected to be very persistent in the environment and is therefore is considered not of concern. Al so the estimated Bioconcentration factor (BCF) is 73.29 L/kg wet - wt which is not expected to be of a concern either. X. E COTOXICITY The Ecological Structure Activity Relationships (ECOSAR) Class Program was used to estimate the aquatic toxicity of industr ial chemicals. The results of the ECOSAR Program are presented below. ECOSAR v1.00 Class Found: Amides ECOSAR Class/ Organism/ Duration/ End Pt/ Predicted mg/L (ppm)34 Amides: Fish 96 - hr LC 50 - 2.249 Amides: Daphnid 48 - hr LC 50 – 2.006 Amides: Green Algae 9 6 - hr EC 50 – 0.185 Neutral Organic SAR (Baseline Toxicity): Fish 96 - hr LC 50 – 11.357 Daphnid 48 - hr LC 50 - 7.697 Green Algae 96 - hr EC 50 – 5.731 The ECOSAR predictions are reasonably close when compared with the experimental test results from BASF MSDS a nd the ISP MSDS. BASF MSDS: Acute toxicity to fish: zebra fish/LC 50 (96h): >12.3 - < 44.8 mg/l Acute toxicity to aquatic invertebrates: Daphnia magna /EC 50 (48h): 12.2 mg/l Toxicity to aquatic plants: green algae/EC 50 (96 h): 6.2 mg/l; green algae/E C 50 (72 h): 19.0 mg/l ISP MSDS: 96 hr. Static LC 50 (Bluegill s unfish): 22.5 mg/L 48 hr. Static EC 50 (Daphnia Magna): 19.1 mg/L 96 hr. Static EC 50 (Selenatrum Capricornutum): 6.20 mg/L; 96 hr. NOEC: 3.26 mg/L 96 hr. Flow - through LC 50 = 17.8 mg/L (Rainbow Tr out) Bobwhite quail LD 50 : 1,838 mg/kg (acute oral) Bobwhite quail LC 50 : >5,620 ppm (dietary) Based on the studies mentioned in the BASF and ISP MSDS it can be assumed that N - (n octyl) - 2 - pyrrolidone is slightly toxic to aquatic fish on an acute basis. Also it can be assumed that N - (n - octyl) - 2 - pyrrolidone is slightly toxic to aquatic invertebrates on an acute basis. N - (n - octyl) - 2 - pyrrolidone is also slightly toxic to bobwhite quail on an acute basis. It is practically non - toxic to bobwhite quail on a chronic basis based on the dietary LC 50 . Overall N - (n - octyl) - 2 - pyrrolidone is not expected to be of great concern with respect to ecotoxicity. XI . R ISK CHARACTERIZATION Wagner Regulatory Associates (7217 Lancaster Pike, Suite A. Hockessin, DE 19707) on behalf of Nichino America, Inc. (4550 New Linden Hill Road, Suite 501, Wilmington, DE 19808) is requesting that EPA expand the current N - (n - octyl) - 2 - pyrrolidone (NOP) tolerance exemption. N - (n - octyl) - 2 - pyrrolidone (CAS Reg. No. 2687 - 94 - 7) is currently approved f or an inert ingredient tolerance exemption listed in 40 CFR 180.1130 when used as a solvent in cotton defoliant formulations containing thidiazuron and diuron as active ingredients. Wagner Regulatory Associates requested that EPA expand it to include use a s an inert ingredient35 (solvent) in formulations of pyraflufen - ethyl herbicide at a maximum concentration of 20% weight/weight. N - (n - octyl) - 2 - pyrrolidone has low acute toxicity. T he acute oral LD 50 = 2,050 mg/kg for rats (Toxiccity Category III). The acute dermal LD 50 > 2,000 mg/kg in rabbits (Toxicity category III) . A p rimary skin irritation study on rabbits showed that N - (n - octyl) - 2 - pyrrolidone is extremely irritating. The dermal sensitization study on guinea pigs was considered positive. No acute inhalat ion study was available in the database. There were three subchronic oral toxicity studies available in the database. A 28 - day oral toxicity study in rats showed changes in general health, reduction in body weight gain and changes in hematological and bio chemical parameters following treatment with 320 mg/kg/day, the highest dose tested, of N - (n - octyl) - 2 - pyrrolidone. The NOAEL = 55 mg/kg/day. In a 90 - day oral toxicity study in rats signs of systemic toxicicty, reduced body weight gain and/or food consumpti on, increase absolute and relative liver weights and minimal to mild hepatocyte hypertrophy were observed at 6000 ppm, the highest dose tested. The NOAEL was 600 ppm (53 mg/kg/day). In a 90 - day oral toxicity study in dogs, a dose - related increase in both a bsolute and relative liver weights, neurological signs and body weight loss were observed at 90 mg/kg/day. The NOAEL was 30 mg/kg/day. There were three mutagenicity and genoto xic i ty studies available in the database for N - (n - octyl) - 2 - pyrrolidone. An Ames test, a mouse lymphoma mutagenesis assay and a mouse micronucleus test were negative for mutagenicity and genotoxicity. No carcinogenicity studies were available in the database for N - (n - octyl) - 2 - pyrrolidone . The Agency used a qualitative structure acti vity relationship (SAR) database, DEREK11, to determine if there were structural alerts for potential carcinogenicity of for N - (n - octyl) - 2 - pyrrolidone . No structural alerts for carcinogenicity were identified for N - (n - octyl) - 2 - pyrrolidone. In the absence o f any structural alerts and lack of mutagenicity concerns, N - (n octyl) - 2 - pyrrolidone is not expected to be carcinogenic. There was one developmental toxicity study for N - (n - octyl) - 2 - pyrrolidone performed on rats, which were dosed at 0, 50, 200 and 800 mg/ kg bw/day. The maternal NOAEL was determined to be 200 mg/kg bw/day and the maternal LOAEL was 800 mg/kg bw/day based on ruffled fur, ventral recumbency, somnolence, apathy, dyspnea and comatose state. Other adverse effects observed were a reduction in foo d consumption and slight body weight loss during the first days of dosing and reduced corrected body weight gain. The developmental NOAEL was 200 mg/kg and the developmental LOAEL was 800 mg/kg based on statistically significantly reduced body weight and d elay in skeletal ossification correlated with the severe maternal toxicity observed at this dosage. There were no reproductive toxicity studies for N - (n - octyl) - 2 - pyrrolidone. While there are no reproductive, neurotoxicity and chronic toxicity studies for N - (n - octyl) - 2 - pyrrolidone , there is no evidence of effects on reproductive parameters or of any effects suggestive of neurotoxicity from the available subchronic studies.36 No immunotoxicity or neurotoxicity studies were available in the database for N - ( n octyl) - 2 - pyrrolidone . No metabolism or pharmacokinetic studies were available in the database for N - (n - octyl) - 2 - pyrrolidone . Section 408 of the Federal Food, Drug and Cosmetic Act (FFDCA) provides that EPA shall apply an additional margin of safety fo r infants and children in the case of threshold effects to account for prenatal and post natal toxicity and the completeness of the database on toxicity and exposure unless EPA determines that a different margin of safety will be safe for infants and child ren. EPA concludes that the FQPA safety factor could be reduced from 10X to 3 X for N - (n octyl) - 2 - pyrrolidone based on lack of increased susceptibility of infants and children from exposures to N - (n - octly) - 2 - pyrrolidone, lack of neurotoxicity and immunotox icity concerns and completeness of the database for risk assessment purpose. An acute toxicity endpoint was not established because no endpoint of concern following a single exposure was identified in the available studies. A toxicity endpoint for chron ic dietary assessment and inhalation and dermal exposure assessment was selected at 30 mg/kg/day based on the 90 - day toxicity study in dogs. This was based on changes in clinical pathological parameters (decrease in A/G ratio and increase in alkaline phosp hatase and globulin and decrease in RBC, Hgb, Hct, albumin, and GGT) and statistically significant dose - related increases in both absolute and relative liver weights at the LOAEL of 90 mg/kg/day. An uncertainty factor 3 00 was for inter - species extrapolatio n (10X) , intra - individual variability (10X) and FQPA safety factor (3X) . An acute dietary risk assessment was not conducted because no endpoint of concern following a single exposure was identified in the available studies. A chronic dietary risk asses sment was conducted using the endpoint from the 90 - day dog study. Based on the analysis of estimated dietary risks for the total U.S. population and various population subgroups, the chronic dietary exposure estimates for N - (n - octyl) - 2 - pyrrolidone are belo w the Agency’s level of concern for all supported commodities with active pyraflufen ethyl registrations. The chronic dietary exposure estimates for the total U.S. population is 14.3 % and the highest exposed population subgroup, children 1 - 2 years old, is 59.4 % of the chronic population adjusted dose (cPAD). A cancer dietary exposure assessment was not conducted because the Agency has not identified a cancer risk for N - (n - octyl) - 2 - pyrrolidone. The term “residential exposure” is used in this document to refer to non - occupational, non - dietary exposure (e.g., for lawn and garden pest control, indoor pest control, termiticides, and flea and tick control on pets). N - (n - octyl) - 2 - pyrrolidone may be used in inert ingredients in pesticide products that are regis tered for specific uses that may result in outdoor residential exposures. Based on the use pattern of the active ingredient which includes but is not limited to gol f courses, ornamental turf lawns, roadside, parks and sports fields, the major route of expo sure is expected to be inhalation and dermal exposure. A screening level residential37 exposure and risk assessment was completed for a representative sample product containing pyraflufen ethyl. The 20% limit of formulation for N - (n - octyl) - 2 - pyrrolidone and total application rate of 0.0163 lbs of inert ingredient per half acre was used for risk assessment. For residential applicator exposure, three use scenarios were used based on the sample label, manually pressurized hand - wand, backpack sprayer and hose - end sprayer. The Margins of Exposures (MOEs) were calculated to be 51000, 25000 and 11000 respectively. The acceptable MOE is for N - (n - octyl) - 2 - pyrrolidone is 3 00 or above; therefore these scenarios do not exceed the Agency’s level of concern. For resi dential post - application exposure, adults and toddlers were assessed separately as well as a golfer scenario . The adult contact consists of dermal post - application contact with turf while the toddler scenarios include oral hand to mouth, incidental oral in gestion, oral object to mouth and dermal turf contact. The resulting MOEs were 2420 for adults and 686 for a total toddler combined exposure for all the scenarios. The acceptable MOE for N - (n - octyl) - 2 - pyrrolidone is 3 00 or above; therefore residential post - application exposures do not exceed the Agency’s level of concern for N - (n - octyl) - 2 - pyrrolidone. Short - term residential aggregate exposure takes into account short - term residential exposure plus chronic exposure to food and water (considered to be a b ackground exposure level). N - (n - octyl) - 2 - pyrrolidone is used as an inert ingredient in some pesticide products that are currently registered for uses that could result in short - term residential exposure . The adult short term aggregate MOE was calculated to be 1122 and the toddler aggregate MOE to be 291. Registration Division’s levels of concern are for MOEs that are less than 3 00, therefore the aggregate exposure MOE are not of concern. Occupational exposure scenarios selected by the Agency for assessm ent are evaluated based on likely maximum application rates for products which m ay contain the inert ingredient. T he example label and the same application rates were used for the intermediate - and long - term exposure durations . Active ingredient applicati on rates are corrected for the maximum amount of inert ingredient (20% limit) present in the final formulations to determine exposure and risk from exposure to the inert ingredient. The acceptable MOE for N - (n - octyl) - 2 - pyrrolidone is set at 3 00 or above f or occupational exposure assessment. Based on the sample label , the occupational exposure scenarios for ground applicators and for mixer/loaders preparing and applying liquid formulations were used. These are the occupational activities believed to be asso ciated with the highest exp osures relative to the proposed label use patterns. Due to the lack of data to the contrary, dermal absorption is assumed to be 100%. The inhalation toxicity and dermal toxicity was also assumed to be equivalent to oral toxicity. Risks were calculated using the MOE approach, which is a ratio of the exposure to the toxicological point of departure (PoD). Occupational handler risks consisted of MOEs ranging from 4,200 to 4,200,000 and are considered not of concern. The Agency’s leve l of concern for occupational inhalation and dermal exposure for N - (n - octyl) - 2 - pyrrolidone is for MOEs < 3 00. Occupational post - application exposure is used to describe exposures that occur when individuals are present in an environment that has been pr eviously treated with a pesticide (also referred to as re - entry exposure). Such exposures may occur when workers enter previously38 treated areas to perform job functions, including activities related to crop production, such as scouting for pests or harvest ing. This assessment is considered to be a screening level assessment, demonstrating that there are minimal potential risks to workers re - entering fields treated with pesticides containing N - (n - octyl) - 2 - pyrrolidone as inert ingredients. Therefore an occupa tional post - application risk assessment was not performed. EPA has not found N - (n - octyl) - 2 - pyrrolidone to share a common mechanism of toxicity with any other substances, and that N - (n - octyl) - 2 - pyrrolidone does not appear to produce a toxic metabolite p roduced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that N - ( - n - octyl) - 2 - pyrrolidone do es not have a common mechanism of toxicity with other substances. Potential areas of environmental justice concerns, to th e extent possible, were considered in this human health risk assessment, in accordance with U.S. Executive Order 12898, "Federal Actions to Address Environmental Justice in Minority Populations and Low - Income Populations," http://www.eh.doe.gov/oepa/guidance/justice/eo12898.pdf . Environmental fate data for N - (n - octyl) - 2 - pyrrolidone could not be found in the publically available scientific literature. The EPI (Estimation Programs Interf ace) Suite TM was used to model possible environmental fate properties of the N - (n - octyl) - 2 - pyrrolidone. Based on the estimated modeling programs, N - (n - octyl) - 2 - pyrrolidone is believed to be readily biodegradable. Also based on the modeling, N - (n - octyl) - 2 - p yrrolidone is estimated to have a Log Kow of 3.33 which can be assumed to be only slightly mobile in soils when converted to Log Koc. With primary biodegradation estimated to be days and ultimate biodegradation to occur in weeks, N - (n - octyl) - 2 - pyrrolidone is not expected to be very persistent in the environment and is therefore considered not of concern. The estimated Bioconcentration factor (BCF) is 73.29 which is also not expected to be of a concern The Ecological Structure Activity Relationships (ECOSA R) Class Program was used to estimate the aquatic toxicity of industrial chemicals. However study citations were also provided from both BASF and ISP MSDS. The ECOSAR predictions were reasonably close when compared with the experimental test results from B ASF MSDS and the ISP MSDS. Based on the studies mentioned in the BASF and ISP MSDS it can be assumed that N - (n - octyl) - 2 - pyrrolidone is slightly toxic to aquatic fish on an acute basis. Also it can be assumed that N - (n - octyl) - 2 - pyrrolidone is slightly toxic to aquatic invertebrates on an acute basis. N - (n - octyl) - 2 - pyrrolidone is also slightly toxic to bobwhite quail on an acute basis. It is practically non - toxic to bobwhite quail on a chronic basis based on the dietary LC50. Overall N - (n - octyl) - 2 - pyrrolidone is not expected to be of great concern with respect to ecotoxicity. Taking into consideration all available information on N - (n - octyl) - 2 - pyrrolidone, EPA concludes that there is a reasonable certainty that no harm to any population subgroup will result from aggregate exposure to N - (n - octyl) - 2 - pyrrolidone when considering occupational, dietary exposure and all other nonoccupational sources of pesticide exposure for which there is reliable information. Therefore, the amendment of an exemption from toleran ce under 40 CFR 180.1130 for N - (n - octyl) - 2 - pyrrolidone (CAS Reg. No. 2687 - 94 - 7) when used as a pesticide inert39 ingredient solvent in formulations of pyraflufen ethyl herbicide at a maximum concentration of 20% weight/weight can be considered safe under sec tion 408(q) of the FFDCA.40 REFERENCES MRID 45511801. Nitka S., Palanker A.L. Acute Oral LD50 in Rats of N - (n - octyl) - 2 - pyrrolidone. Testing Facility: Consumer Product Testing Bldg. No. 2 - 15B. 1275 Bloomfield Avenue Fairfield, NJ 07006. Sponsor: Internationa l Specialty Products 1361 Alps Road. Wayne, NJ 07470. Study Completion Date: July 30, 1986. MRID 45511802. Nitka S., Palanker A.L. Acute Dermal Toxicity in Rabbits of N - (n - octyl) - 2 - pyrrolidone. Testing Facility: Consumer Product Testing Bldg. No. 2 - 15B. 1 275 Bloomfield Avenue Fairfield, NJ 07006. Sponsor: International Specialty Products 1361 Alps Road. Wayne, NJ 07470. Study Completion Date: April 23, 1987. MRID 45511803 . Nitka S., Palanker A.L. Primary Ocular Irritation in Rabbits Primary Dermal Irritat ion in Rabbits of N - (n - octyl) - 2 - pyrrolidone. Testing Facility: Consumer Product Testing Bldg. No. 2 - 15B. 1275 Bloomfield Avenue Fairfield, NJ 07006. Sponsor: International Specialty Products 1361 Alps Road. Wayne, NJ 07470. Study Completion Date: June 23, 1986. MRID 45511804. Nitka S., Palanker A.L. D.O.T. Skin Corrosion in Rabbits of N - (n - octyl) - 2 - pyrrolidone. Testing Facility: Consumer Product Testing Bldg. No. 2 - 15B. 1275 Bloomfield Avenue Fairfield, NJ 07006. Sponsor: International Specialty Products 1 361 Alps Road. Wayne, NJ 07470. Study Completion Date: September 24, 1986. MRID 45511805. Smith C. et al. Twenty - Eight Day or al Toxicity in Rat with Surfadone LP - 100 ( N - (n - octyl) - 2 - pyrrolidone). Testing Facility: Huntingdon Research Centre Ltd. P.O. Box 2. Huntingdon, Cambridgeshire PE18 6ES England . Sponsor: International Specialty Products 1361 Alps Road. Wayne, NJ 07470. Study Completion Date: June 30, 1989 . MRID 45511806. Reagan E.L., Laveglia J. Comedogenic Assay of Surfadone LP - 100 (N - (n octyl) - 2 - p yrrolidone) in New Zealand White Rabbits. Testing Facility: Food and Drug Research Laboratories. Division of Enviro/Analysis Corporation. P.O. Box 107 Route 17C. Waverly, NY 14892 - 0107. Sponsor: International Specialty Products 1361 Alps Road. Wayne, NJ 07 470. Study Completion Date: February 29, 1988. MRID 42668316. Liao J.T.F. Surfadone LP - 100 90 - Day Dietary Toxicicty Study in Rats Final Report. Performing Laboratory: Springborn Laboratories, Inc. (SLS) Life Science Division 553 North Broadway Spencervill e, OH 45887. Sponsor: GAF Chemicals Corporation (International Specialty products, Inc.) 1361 Alps Road Wayne, NJ 07470. Study Completion Date: July 2, 1991. MRID 42668317. Liao J.T.F. Surfadone LP - 100 90 - Day Oral (Capsule) Toxicity Study in Dogs Final Re port. Performing Laboratory: Springborn Laboratories, Inc. (SLS) Life Science Division 553 North Broadway Spencerville, OH 45887. Sponsor: GAF Chemicals Corporation (International Specialty products, Inc.) 1361 Alps Road Wayne, NJ 07470. Study Completion D ate: July 2, 1991.41 MRID 42668318. Becker H. Biedermann K. Embryotoxicity Study (Including Teratogenicity) with Surfadone LP 100 in the Rat. Performing Laboratory: RCC Research and Consulting Company AG P.O. Box, CH 4452 Itingen/Switzerland. Study Completi on Date: June 25, 1991. MRID 42668319. Jones E., Wilson L.A. Ames Metabolic Activation Test to Asses the Potential mutagenic Effect of Surfadone LP - 100 Surfactant. Performing Laboratory: Huntingdon Research Centre Ltd. Huntindon, Cambridgeshire. PE18 6ES, England. Sponsor: GAF Chemicals Corporation (International Specialty products, Inc.) 1361 Alps Road Wayne, NJ 07470. Study Completion Date: February 3, 1989. MRID 42668320. Kirby P.E. Evaluation of a Test Article in the L5178Y TK+/ - Mouse Lymphoma Mutage nesis Assay with Colony Size Evaluation in the Presence and absence of Aroclor - induced Rat Liver S - 9. Performing Laboratory: SITEK Research Laboratories. 12111 Parklawn Drive . Rockville. Maryland 20852 . Sponsor: International Specialty products, Inc. 1361 Alps Road Wayne, NJ 07470. Study Completion Date: December 3, 1990 . MRID 42668321. Proudlock R.J., Haynes P., Meaking K. Mouse Micronucleus Test on Surfadone LP - 100 Surfactant. Performing Laboratory: Huntingdon Research Centre Ltd. Huntindon, Cambridgeshi re. PE18 6ES, England Sponsor: GAF Chemicals Corporation (International Specialty products, Inc.) 1361 Alps Road Wayne, NJ 07470. Study Completion Date: April 27, 1989. US EPA (1994) N - (n - Octyl) - 2 - Pyrrolidone and N - (n - Dodecyl) - 2 - Pyrrolidone; Tolerance Exe mptions. US Environmental Protection Agency. Published Date June 22, 1994) US EPA. (2000) Notice of Filing to establish an exemption from the requirement of a tolerance for N (n - octyl) - 2 - pyrrolidone (Agolex 8 ® ) and N(n - dodecyl) - 2 - pyrrolidone (Agolex 12®) when used as an inert ingredient in or on growing crops, when used as an inert ingredient in or on growing crops, when applied to an raw agricultural commodities, or to animals (40 CFR 180.1001(c) and (e)) US Environmental Protection Agency. Published Date : August 30, 2000 . US EPA. (2006) Inert Reassessments: Two Exemptions from the Requirement of a Tolerance for N - (n - dodecyl) - 2 - pyrrolidone (CAS Reg. No. 2687 - 96 - 9) and N - (n - octyl) - 2 - pyrrolidone (CAS Reg. No. 2687 - 94 - 7). US Environmental Protection Agency O ffice of Pollution Prevention and Toxic Substances. June 20, 2006.42 APPENDIX Derek Nexus Report 

## Derek Nexus Report Author HED Report date 08 August 2013 10:03:24 Prediction date 08 August 2013 10:02:28 Program version Derek Nexus: 3.0 .1, Nexus: 1.5.0 Compound name Structure - 2 Species bacterium, mammal Endpoints alpha - 2 - mu - Globulin nephropathy, Anaphylaxis, Bladder urothelial hyperplasia, Carcinogenicity, Cardiotoxicity, Cerebral oedema, Chloracne, Cholinesterase inhibiti on, Chromosome damage in vitro, Chromosome damage in vivo, Cumulative effect on white cell count and immunology, Cyanide - type effects, Developmental toxicity, Genotoxicity in vitro, Genotoxicity in vivo, Hepatotoxicity, HERG channel inhibition in vitro, Hi gh acute toxicity, Irritation (of the eye), Irritation (of the gastrointestinal tract), Irritation (of the respiratory tract), Irritation (of the skin), Lachrymation, Methaemoglobinaemia, Mutagenicity in vitro, Mutagenicity in vivo, Nephrotoxicity, Neuroto xicity, Occupational asthma, Ocular toxicity, Oestrogenicity, Peroxisome proliferation, Phospholipidosis, Photo - induced chromosome damage in vitro, Photoallergenicity, Photocarcinogenicity, Photogenotoxicity in vitro, Photogenotoxicity in vivo, Photomutage nicity in vitro, Phototoxicity, Pulmonary toxicity, Rapid prototypes: adrenal gland toxicity, Rapid prototypes: bladder disorders, Rapid prototypes: blood in urine, Rapid prototypes: bone marrow toxicity, Rapid prototypes: bradycardia, Rapid prototypes: ca rdiotoxicity, Rapid prototypes: chromosome damage in vitro, Rapid prototypes: hepatotoxicity, Rapid prototypes: kidney disorders, Rapid prototypes: mitochondrial dysfunction, Rapid prototypes: nephrotoxicity, Rapid prototypes: splenotoxicity, Rapid prototy pes: testicular toxicity, Rapid prototypes: thyroid toxicity, Respiratory sensitisation, Skin sensitisation, Teratogenicity, Testicular toxicity, Thyroid toxicity, Uncoupler of oxidative phosphorylation Superendpoints Carcinogenicity (SUPER), Chromoso me damage (SUPER), Genotoxicity (SUPER), Hepatotoxicity (SUPER), HERG channel inhibition (SUPER), Irritation (SUPER), Miscellaneous endpoints (SUPER), Mutagenicity (SUPER), Ocular toxicity (SUPER), Rapid prototypes: adrenal gland toxicity (SUPER), Rapid pr ototypes: bladder disorders (SUPER), Rapid prototypes: blood in urine (SUPER), Rapid prototypes: bone marrow toxicity (SUPER), Rapid prototypes: bradycardia (SUPER), Rapid prototypes: cardiotoxicity (SUPER), Rapid prototypes: chromosome damage in vitro (SU PER), Rapid prototypes: hepatotoxicity (SUPER), Rapid prototypes: kidney disorders (SUPER), Rapid prototypes: mitochondrial dysfunction (SUPER), Rapid prototypes: nephrotoxicity (SUPER), Rapid prototypes: splenotoxicity43 (SUPER), Rapid prototypes: testicula r toxicity (SUPER), Rapid prototypes: thyroid toxicity (SUPER), Reproductive toxicity (SUPER), Respiratory sensitisation (SUPER), Skin sensitisation (SUPER), Thyroid toxicity (SUPER) Constraints Perceive tautomers true Perceive mixtures true Perceive alerts without rules false Average molecular mass 197.32 (Lhasa Limited, version 1.0) Exact molecular mass 197.178 (Lhasa Limited, version 1.0) Log Kp

- 1.57 (Potts & Guy, version 1.0 (LogP: BioByte Corp., version 5.3; Average Molecular Mass: Lhasa Limited, version 1.0)) Log P 3.31 (BioByte Corp., version 5.3) 

### Submitted compound



### Predictions **Derek KB 2012 1.0** KnowledgeBase name Derek KB 2012 1.0 KnowledgeBase version 1.0 KnowledgeBase last modified 29 November 20 12 11:56:30 KnowledgeBase location C:/Program Files/Lhasa Limited/Lhasa Knowledge Suite - Nexus 1.5/KnowledgeBases/org.lhasalimited.pluto.knowledge.derek_1.0.744 KnowledgeBase certified by Lhasa Limited, Leeds, Yorkshire, UK Nothing to report 

### Reasoning glossary: Certain There is proof that the proposition is true. Probable There is at least one strong argument that the proposition is true and there are no arguments against it. Plausible The weight of evidence supports the prop osition. Equivocal There is an equal weight of evidence for and against the proposition. Doubted The weight of evidence opposes the proposition. Improbable There is at least one strong argument that the proposition is false and there are no arguments that it is true Impossible There is proof that the proposition is false. Open There is no evidence that supports or opposes the proposition. Contradicted There is proof that the proposition is both true and false.45 Chronic DEEM Output File US EPA Ver. 3.16, 03 - 08 - d DEEM - FCID Chronic analysis for HERBICIDE TOLERANCES NHANES 2003 - 2008 2 - day Residue file name: E: \ DEEM \ N - (n - octyl) - 2 - pyrrolidone \ N - (n - octyl) - 2 - pyrrolidone - 300UF - Pyraflufen - ethyl only - Limit Test 20% - cotton fixed.R08 Adjustment factor #2 used. Analysis Date 02 - 04 - 2014/09:39:33 Residue file dated: 02 - 04 - 2014/08:43:47 Refe rence dose (RfD, Chronic) = .1 mg/kg bw/day COMMENT 1: Inert Herbicides Only + 100ppb H2O (Pyraflufen Ethyl Only Limit 20% +cotton) =============================================================================== Total exposure by popula tion subgroup

------------------------------------------------------------------------------- Total Exposure

----------------------------------- Populat ion mg/kg Percent of

Subgroup body wt/day Rfd

-------------------------------------- ------------- ---------------- Total US Population 0.014323 14.3% Hispanic 0.016276 16.3% Non - Hisp - White 0.013779 13.8% Non - Hisp - Black 0.014223 14.2% N on - Hisp - Other 0.016768 16.8% Nursing Infants 0.016287 16.3% Non - Nursing Infants 0.041560 41.6% Female 13+ PREG 0.012300 12.3% Children 1 - 6 0.047178 47.2% Children 7 - 12 0.021230 21.2% Male 13 - 19 0.013005 1 3.0% Female 13 - 19/NP 0.011886 11.9% Male 20+ 0.009928 9.9% Female 20+/NP 0.009323 9.3% Seniors 55+ 0.008876 8.9% All Infants 0.033758 33.8% Female 13 - 50 0.010013 10.0% Children 1 - 2 0.059367 59.4% Children 3 - 5 0.041883 41.9% Children 6 - 12 0.023487 23.5% Youth 13 - 19 0.012444 12.4% Adults 20 - 49 0.010126 10.1% Adults 50 - 99 0.009008 9.0% Female 13 - 49 0.010055 10.1%

-------------------------------------------------------- -----------------------46 Chronic DEEM Input File Filename: E: \ DEEM \ N - (n - octyl) - 2 - pyrrolidone \ N - (n - octyl) - 2 - pyrrolidone - 300UF - Pyraflufen - ethyl only - Limit Test 20% cotton fixed.TXT Chemical: Herbicide Tolerances RfD(Chronic): .1 mg/kg bw/day NOEL(C hronic): .1 mg/kg bw/day RfD(Acute): 0 mg/kg bw/day NOEL(Acute): 0 mg/kg bw/day Date created/last modified: 11 - 20 - 2013/12:08:41 Program ver. 3.16, 03 - 08 - d Comment: Inert Herbicides Only + 100ppb H2O (Pyraflufen Ethyl Only Limit 20% +cotton)

------- ---------------------------------------------------------------------------- EPA Crop Def Res Adj.Factors Comment Code Grp Commodity Name (ppm) #1 #2

---------- ---- ---- --------------------------- ---------- ------ ------ ------- 0103296000 1C Potato, chips 1.000000 1.000 0.400 diuron 0103297000 1C Potato, dry (granules/ flakes) 1.000000 6.500 0.400 diuron 0103297001 1C Potato, dr y (granules/ flakes) - b 1.000000 6.500 0.400 diuron 0103298000 1C Potato, flour 1.000000 1.000 0.400 diuron 0103298001 1C Potato, flour - babyfood 1.000000 1.000 0.400 diuron 0103299000 1C Potato, tuber, w/ peel 1.000000 1.000 0.400 diuron 0103299001 1C Potato, tuber, w/peel - babyfood 1.000000 1.000 0.400 diuron 0103300000 1C Potato, tuber, w/o peel 1.000000 1.000 0.400 diuron 0103300001 1C Potato, tuber, w/o peel - babyfood 1.000000 1.000 0.400 diuron 0600347000 6 Soybean, seed 20.000000 1.000 0.400 glypho Full comment: glyphosate 0600349000 6 Soybean, soy milk 20.000000 1.000 0.400 glypho Full comment: glyphosate 0600349001 6 Soybean, soy milk - babyfood or in 20.000000 1.000 0.400 glypho Full comment: glyphosate 0600350000 6 Soybean, oil 20.000000 1.000 0.400 glypho Full comment: glyphosate 0600350001 6 Soybean, oil - babyfood 20.000000 1.000 0.400 glypho Full comment: glyphosate 0603348000 6C Soybean, flour 20.000000 1.000 0.400 glypho Full comment: glyphosate 06033 48001 6C Soybean, flour - babyfood 20.000000 1.000 0.400 glypho Full comment: glyphosate 1100007000 11 Apple, fruit with peel 5.000000 1.000 0.400 2,4 - D 1100008000 11 Apple, peeled fruit 5.000000 1.000 0.400 2,4 - D 1100008001 11 Apple, peeled fruit - babyfood 5.000000 1.000 0.400 2,4 - D 1100009000 11 Apple, dried 5.000000 8.000 0.400 2,4 - D 1100009001 11 Apple, dried - babyfood 5.000000 8.000 0.400 2,4 - D 1100010000 11 Apple, juice 5.000000 1.300 0.400 2,4 - D 1100010001 11 Apple, juice - babyfood 5.000000 1.300 0.400 2,4 - D 1100011000 11 Apple, sauce 5.000000 1.000 0.400 2,4 - D 1100011001 11 Apple, sauce - babyfood 5.000000 1.000 0.400 2,4 - D 1100129000 11 Crabapple 5.000000 1.000 0.400 2,4 - D 1100210000 11 Loquat 5.000000 1.000 0.400 2,4 - D 1100266 000 11 Pear 5.000000 1.000 0.400 2,4 - D 1100266001 11 Pear - babyfood 5.000000 1.000 0.400 2,4 - D 1100267000 11 Pear, dried 5.000000 6.250 0.400 2,4 - D 1100268000 11 P ear, juice 5.000000 1.000 0.400 2,4 - D 1100268001 11 Pear, juice - babyfood 5.000000 1.000 0.400 2,4 - D 1100310000 11 Quince 5.000000 1.000 0.400 2,4 - D 1201090000 12A Cherry 0.250000 1.000 0.400 simazi Full comment: simazine 1201090001 12A Cherry - babyfood 0.250000 1.000 0.400 simazi Full comment: simazine 1201091000 12A Cherry, juice 0.250000 1.500 0.400 simazi Full comment: simazine 1201091001 12A Cherry, juice - babyfood 0.250000 1.500 0.400 simazi Full comment: simazine 1202012000 12B Apricot 5.000000 1.000 0.400 2,4 - D 1202012001 12B Apricot - babyfood 5.000000 1.000 0.400 2,4 - D 1202013000 12B Apricot, dried 5.000000 6.000 0.400 2,4 - D 1202014000 12B Apricot, juice 5.000000 1.000 0.400 2 ,4 - D 1202014001 12B Apricot, juice - babyfood 5.000000 1.000 0.400 2,4 - D 1202230000 12B Nectarine 0.250000 1.000 0.400 simazi Full comment: simazine [peach transl] 1202260000 12B Peach 0.250000 1.000 0.400 simazi Full comment: simazine47 1202260001 12B Peach - 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bab yfood 0.250000 1.400 0.400 simazi Full comment: simazine 1304175000 13D Grape 1.000000 1.000 0.400 diuron 1304176000 13D Grape, juice 1.000000 1.200 0.400 diuron 1304176001 13D Grape, juice - babyfood 1.000000 1.200 0.400 diuron 1304179000 13D Grape, wine and sherry 1.000000 1.000 0.400 diuron 1400003000 14 Almond 1.000000 1.000 0.400 glypho Full comment: glyphosate 1400003001 14 Almond - babyfood 1.000000 1.000 0.400 glypho Full comment: glyphosate 1400004000 14 Almond, oil 1.000000 1.000 0.400 glypho Full comment: glyphos ate 1400004001 14 Almond, oil - babyfood 1.000000 1.000 0.400 glypho Full comment: glyphosate 1400059000 14 Brazil nut 1.000000 1.000 0.400 glypho Full comment: glyphosate 1400068000 1 4 Butternut 1.000000 1.000 0.400 glypho Full comment: glyphosate 1400081000 14 Cashew 1.000000 1.000 0.400 glypho Full comment: glyphosate 1400092000 14 Chestnut 1.000000 1.000 0.400 glypho Full comment: glyphosate 1400155000 14 Hazelnut 1.000000 1.000 0.400 glypho Full comment: glyphosate 1400156000 14 Hazelnut, oil 1.000000 1.000 0.400 glypho Full comment: glyphosate 1400185000 14 Hickory nut 1.000000 1.000 0.400 glypho Full comment: glyphosate 1400213000 14 Macadamia nut 1.000000 1.000 0.400 glypho Full comment: glyphosate 1400269000 14 Pecan 1.000000 1.000 0.400 glypho Full comment: glyphosate 1400282000 14 Pistachio 1.000000 1.000 0.400 glypho Full comment: glyphosate 1400391000 14 Walnut 1.000000 1.000 0.400 glypho Full comment: glyphosate 1500120000 15 Corn, field, flour 1.000000 1.000 0.400 glypho Full comment: glyphosate 1500120001 15 Corn, field, flour - 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